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Severe Diabetic Ketoacidosis in the Canagliflozin Type 2 Diabetes Clinical Program
September 2015. This study evaluated the incidence of serious diabetic ketoacidosis (DKA) in 17,596 patients with type 2 diabetes enrolled in the clinical drug development program for the sodium-glucose transport-2 (SGLT-2) inhibitor canagliflozin. Investigators found that DKA occurred at a low frequency in patients taking canagliflozin. Overall, 12 patients experienced severe DKA; of these 4 were receiving canagliflozin 100 mg, 6 were taking canagliflozin 300 mg, and 2 were treated with a comparator drug. Most patients who experienced DKA had a blood glucose level >300 mg/dL and were on insulin. You can read the study abstract here.
FDA Drug Safety Communication: FDA Warns That DPP-4 Inhibitors for Type 2 Diabetes May Cause Severe Joint Pain
August 28, 2015. The US Food and Drug Administration (FDA) has issued a warning that the dipeptidyl peptidase-4 (DPP-4) inhibitors used to treat type 2 diabetes (sitagliptin, saxagliptin, linagliptin, and alogliptin) may cause joint pain that can be severe and disabling. Because of this, the FDA has added a new Warning and Precaution about this risk to the labels of all DPP-4 inhibitors. The FDA advises that patients should not stop taking DPP-4 inhibitors but should contact their health care professional right away if they experience severe and persistent joint pain. Likewise, health care professionals should consider DPP-4 inhibitors as a possible cause of severe joint pain and discontinue the drug if appropriate. You may follow this link to read the full FDA press release.
Cardiovascular Study of Sodium-Glucose Co-transporter 2 Inhibitor Empagliflozin May Be the First to Show Cardiovascular Benefit
August 27, 2015. The manufacturers of empagliflozin have announced positive top-line results from EMPA-REG Outcome, a clinical trial investigating cardiovascular (CV) outcomes with the sodium glucose co-transporter 2 (SGLT2) inhibitor empagliflozin. The study followed more than 7000 adults from 42 countries for a median of 3.1 years; participants had type 2 diabetes (T2D), were at high risk for CV events and received empagliflozin alongside usual care. The primary endpoint was time to first occurrence of either CV death, nonfatal myocardial infarction, or nonfatal stroke. The study first tested for empagliflozin non-inferiority and then for superiority. Investigators report that the study met its primary outcome and demonstrated superiority for empagliflozin. Comprehensive results will be presented in September at the 51st European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden. You can read a media summary here (MedPage), and the manufacturer’s press release here.
Efficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes: The SCALE Diabetes Randomized Clinical Trial
August 18, 2015. This 56-week, randomized, double-blind, placebo-controlled, parallel-group trial was performed to evaluate the safety of liraglutide (1.8 mg/day or 3.0 mg/day) vs placebo for weight management in overweight or obese adults with type 2 diabetes. Inclusion criteria were body mass index ≥27.0 kg/m2, age ≥18 years, taking 0 to 3 oral diabetes agents (metformin, thiazolidinedione, sulfonylurea), and with A1C levels ranging from 7.0% to 10.0%. The study had 3 co-primary endpoints: relative weight change and proportion of participants losing ≥5% or >10% of initial body weight. Patients (N=846) were recruited from 126 sites in 9 countries. Investigators found that patients receiving liraglutide 3.0 mg had a mean 6.4 kg weight loss (6.0% of body weight), compared with 5.0 kg (4.7%) for liraglutide 1.8 mg, and 2.2 kg (2.0%) for placebo. The proportion of patients experiencing weight loss ≥5% of baseline body weight was 54.3% with liraglutide 3.0 mg, 40.4% with liraglutide 1.8 mg, and 21.4% with placebo. The proportion with weight loss >10% was 25.2% with liraglutide 3.0 mg, 15.9% with liraglutide 1.8 mg, and 6.7% with placebo. You can follow this link to read the study abstract.
Sulfonylureas and Risk of Falls and Fractures Among Nursing Home Residents With Type 2 Diabetes Mellitus
August 2015. It is known that sulfonylurea drugs increase hypoglycemia, which may in turn increase the risk of patients’ falling and incurring bone fractures. However, evidence is limited and inconsistent regarding the specific association between sulfonylurea use and falls/fractures. This propensity-matched retrospective cohort study evaluated 12,327 long-term nursing home patients. Medicare data were used to identify hypoglycemic events and hospitalizations for fracture/falls in patients with type 2 diabetes initiated on monotherapy with sulfonylureas or metformin. Investigators found that falls were common in all patients (37.4 per 100 person-years). Sulfonylurea use was not associated with a higher fracture risk but was associated with an increased fall rate among nursing home residents with moderate limitations in activities of daily living (ADL) (hazard ratio 1.13; 95% confidence interval, 1.00-1.26). No elevated falling risk was observed for patients with minimal ADL limitations. You can read the study abstract at this link.
Safety and Efficacy of Liraglutide in Patients With Type 2 Diabetes and End-Stage Renal Disease
August 17, 2015. This placebo-controlled, double-blind, parallel group, randomized trial compared 24 patients with type 2 diabetes (T2D) and end-stage renal disease (ESRD) with 23 control patients with T2D and normal kidney function. Patients were randomly allocated on a 1:1 basis to 12 weeks of subcutaneously injected liraglutide (titrated to 1.8 mg) or placebo. The primary outcome was dose-corrected plasma trough liraglutide concentrations. Investigators found that plasma trough liraglutide concentrations were increased by 49% in patients with ESRD who received liraglutide (P=0.02). Additionally, patients with ESRD treated with liraglutide had a higher incidence of gastrointestinal side effects (nausea and vomiting; P<0.04) compared to patients with normal kidney function treated with liraglutide. The investigators concluded that lower liraglutide treatment doses and/or a prolonged titration phase may be advisable when treating patients with ESRD. Follow this link to read the study abstract.
Consumption of Sugar-Sweetened Beverages, Artificially Sweetened Beverages, and Fruit Juice and Incidence of Type 2 Diabetes: Systematic Review, Meta-Analysis, and Estimation of Population Attributable Fraction
July 21, 2015. This systematic review and random effects meta-analysis examined the association between the consumption by patients with type 2 diabetes (T2D) of: a) sugar-sweetened beverages; b) artificially sweetened beverages; and c) fruit juice. Data were adjusted for adiposity. Before adjustment, the daily consumption of a single serving of a sugar-sweetened beverage was associated with an 18% increased incidence of T2D (95% confidence interval [CI]: 9% to 28%). After adjustment, this risk was 13% (95% CI 6% to 21%). The risk associated with artificially sweetened beverages could not be assessed due to confounding and publication bias, and findings were non-significant for fruit juice. Last, the authors estimated the population attributable fraction (PAF)—the proportion of overall cases attributable to a specific risk factor—for sugar-sweetened beverages on T2D incidence. They estimated that 1.8 million of the 20.9 million US T2D diagnoses anticipated over the next 10 years will be attributable to sugar-sweetened beverage consumption (PAF 8.7%). Data were also reported for the United Kingdom. Follow this link to read the abstract and download the full article.
An Observational Study of Patient Characteristics and Mortality Following Hypoglycemia in the Community
June 30, 2015. In this prospective, observational study, data from emergency services calls for hypoglycemia were recorded. The study ran from 2005 to 2013 in an area covering 34,000 patients with diabetes. Variables analyzed included capillary blood glucose (BG), A1C levels, treatment administered for hypoglycemia, as well as subsequent 12-month mortality rates and factors predicting survival. Participants (n=1156) experienced 1835 episodes; 45% had type 1 diabetes (T1D) and 44% had type 2 diabetes (T2D); the remainder were not classified by diabetes type. BG and A1C at presentation were 31.7 mg/dL and 8.3% in patients with T1D, respectively, and 35.3 mg/dL and 7.8% in patients with T2D. Subsequent 1-year mortality was 4.5% in patients with T1D and 22.1% in T2D. Follow this link to read the full article.
Meal Memory—A Useful, Low-Hassle Diabetes App
July 27, 2015. This week’s issue of diaTribe gives a thumbs-up to a new diabetes app called Meal Memory, available free for Apple and Android. Here’s how it works: users take a picture of every meal; their associated pre/post-meal blood glucose measures are paired with the meal to provide a clear visualization of how each meal impacts blood glucose. Patients who use Dexcom Share or Apple Health systems can automatically upload their glucose data to Meal Memory; patients using other meters may need to manually import their data. You can read the diaTribe article here or visit the Meal Memory Web page.
FDA Proposes Additional Revisions to the Nutrition Facts Label
July 27, 2014. The US Food and Drug Administration (FDA) is proposing additional revisions to the Nutrition Facts label for packaged foods. This proposal would require declaration of the percent daily value (%DV) for added sugars, among other changes. The FDA is seeking public comment on the proposal for 75 days. You can follow this link to read the Federal Register announcement and download the full document.
Efficacy and Safety of Liraglutide vs Placebo Added to Basal Insulin Analogues (With or Without Metformin) in Patients With Type 2 Diabetes: A Randomized, Placebo-Controlled Trial
July 2015. This 26-week, double-blind, parallel-group trial was conducted to confirm the superiority of adding liraglutide vs placebo to preexisting treatment with basal insulin plus metformin in patients with inadequately controlled type 2 diabetes (T2D). Patients (N=451) were randomized to liraglutide 1.8 mg once daily (with dose escalation over 2 weeks) or placebo. The primary endpoint was A1C reductions; post-randomization increases to patient insulin doses were not allowed. At 26 weeks, A1C levels were lower with liraglutide (-1.3%) than placebo (-0.1%; P<0.0001). Additionally, more patients on liraglutide achieved the A1C target <7.0% (59% vs 14% on placebo; P<0.0001). Adverse events were more frequent with liraglutide and included nausea (22.2% vs 3.1% for placebo) and minor hypoglycemia (18.2% vs 12.4%). Follow this link to read the study abstract.
Glycemic Control and Hypoglycemia With New Insulin Glargine 300 U/mL vs Glargine 100 U/mL in Patients With Type 2 Diabetes Using Basal Insulin and Oral Antihyperglycemic Drugs
July 2015. This randomized, multicenter, open-label, two-arm study compared the efficacy of insulin glargine 300 U/mL (Gla-300) vs 100 U/mL (Gla-100) in patients with type 2 diabetes treated with basal insulin and oral antihyperglycemic drugs (excluding sulfonylureas). The study (EDITION 2) was conducted over 12 months. Both Gla-300 and Gla-100 were associated with A1C reductions from baseline (-0.55% vs -0.50%, respectively). Patients receiving Gla-300 had a significant 37% relative reduction in confirmed nocturnal hypoglycemia (P=0.031), as well as significantly less weight gain (mean difference, 0.7 kg; P=0.009) compared with Gla-100. The full study abstract is available at this link.
Combination of the Dipeptidyl Peptidase-4 Inhibitor Linagliptin With Insulin-Based Regimens in Type 2 Diabetes and Chronic Kidney Disease
June 22, 2015. Since limited glucose-lowering treatment options are available for type 2 diabetes (T2D) patients with chronic kidney disease (CKD), this study evaluated the safety and efficacy of linagliptin plus insulin in patients with T2D and mild-to-severe renal impairment. Participant data were obtained from 2 phase 3 trials (N=811). After 24 weeks, mean placebo-adjusted A1C reductions from baseline of −0.59% were observed in patients with mild renal impairment and −0.69% in patients with moderate renal impairment. A1C was reduced by −0.43% at 12 weeks in patients with severe renal impairment. Drug-related adverse events with linagliptin were similar to placebo, as was hypoglycemia frequency (hypoglycemia rates in patients with mild, moderate, and severe renal impairment were 34.9%, 35.6%, and 66.7% with linagliptin, and 37.5%, 39.7%, and 49.1% with placebo, respectively). Rates of severe hypoglycemia were low (≤5.6%). The investigators concluded that adding linagliptin to insulin in patients with T2D and CKD improved glucose control and was well tolerated. You can follow this link to read the full article.
A Randomized, Controlled Trial of Liraglutide 3.0 mg in Weight Management
July 2, 2015. This 56-week, double-blind trial included 3731 patients with a body mass index (BMI) of at least 30 kg/m2 (or 27 kg/m2 in individuals with treated or untreated dyslipidemia or hypertension) who did not have type 2 diabetes. Patients were randomly assigned in a 2:1 ratio to receive lifestyle modification counseling plus a once-daily injection of liraglutide 3.0 mg or placebo. The primary endpoints were change in body weight and the proportion of patients losing at least 5% and more than 10% of their initial body weight. At baseline, mean patient age was 45.1 (±12) years, weight was 106.2 (±21.4) kg, and BMI was 38.3 (±6.4) kg/m2. Most of the patients (78.5%) were women and 61.2% had prediabetes. At study end, liraglutide patients had lost a mean of 8.4 (±7.3) kg of body weight vs 2.8 (±6.5) in the placebo group (P<0.001). Among liraglutide patients, 63.2% lost at least 5% of their body weight and 33.1% lost >10%, compared with 27.1% and 10.6%, respectively, of patients in the placebo group. The most common adverse events were mild or moderate nausea and diarrhea, with serious events occurring in 6.2% of liraglutide and 5.0% of placebo patients. Follow this link to read the study abstract.
An Observational Study of Patient Characteristics and Mortality Following Hypoglycemia in the Community
June 30, 2015. This study identified patient characteristics and mortality rates associated with severe hypoglycemic events requiring emergency services intervention. Data (2005-2013) were obtained as part of emergency services calls for hypoglycemia treatment in a UK community with 34,000 residents with diabetes. Investigators identified 1835 hypoglycemic events among 1156 patients, 44% with type 2 diabetes (T2D) and 45% with type 1 diabetes (T1D). Investigators found that patients with severe hypoglycemia and T1D were more likely to be male. In patients with T2D not treated with insulin, severe hypoglycemia was associated with lower A1C levels compared to patients who were insulin users. Last, investigators observed that severe hypoglycemia appeared to be associated with increased 12-month mortality rates, particularly in patients with T2D (T2D, 22.1%; T1D, 4.5%). You can follow this link to read the full article.
Early Specialist Care for Diabetes: Who Benefits Most?
June 25, 2015. This propensity score-matched cohort study examined whether early endocrinologist care reduces the risk of cardiovascular (CV) complications in patients with newly diagnosed diabetes. Patient health data were obtained from Ontario, Canada, provincial records, and patients who were referred to endocrinologist care within 1 year of diagnosis were matched with patients who received primary care alone. Data on patients’ chronic conditions were used to assign a medical complexity score, and outcomes were tracked for 3 to 5 years. The primary outcome was a composite of non-fatal acute myocardial infarction or coronary heart disease death. Other outcomes included major CV events, end-stage renal disease, amputation, and all-cause death. At 3 years, among medically complex patients, early endocrinologist care was associated with a 9% reduction in the primary outcome, and an 11% lower mortality rate. Patients who had ≥3 endocrinologist visits experienced a 31% and 39% reduction in these endpoints. This effect remained persistent at 5 years. Click here to read the article abstract.
Leading Medical Association Announces Scientific and Clinical Review of Potential Relationship Between Diabetes Ketoacidosis and SGLT2 Inhibitors
The American Association of Clinical Endocrinologists (AACE), the leading medical organization representing more than 6000 experts in the care and treatment of diabetes patients, today announced plans to convene a conference of US and international experts to examine the issue of diabetic ketoacidosis (DKA) among patients treated with SGLT2 inhibitors, a class of medications approved for use in adults with type 2 diabetes. AACE will conduct this meeting to provide answers to questions from its membership raised in response to recent case reports and publications on the subject. Link to press release: http://media.aace.com/press-release/leading-medical-association-announces-scientific-and-clinical-review-potential-relatio
Dapagliflozin’s Effects on Glycemia and Cardiovascular Risk Factors in High-Risk Patients With Type 2 Diabetes
June 2015. This 24-week, multicenter, randomized, double-blind, placebo-controlled study with a 28-week extension was developed to assess the efficacy and safety of the selective sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin 10 mg vs placebo in patients with type 2 diabetes, preexisting cardiovascular disease, and a history of hypertension. Co-primary endpoints were A1C reduction from baseline and the proportion of patients achieving a combined endpoint involving reductions in the following parameters: A1C ≥0.5%, body weight ≥3%, and systolic blood pressure ≥3 mm Hg. Compared with placebo, significantly more patients taking dapagliflozin met both endpoints. Specifically, A1C reductions were -0.38% with dapagliflozin vs +0.08% with placebo. Additionally, 11.7% of dapagliflozin patients met the combined endpoint vs 0.9% of placebo patients. These changes were maintained over 52 weeks and were consistent across age groups. Rates of serious adverse events (eg, hypoglycemia, urinary tract disorders, and cardiac disorders) were similar between groups. You can follow this link to read the study abstract.
New Position Statement: Diabetes Self-management Education and Support in Type 2 Diabetes
June 5, 2015. The American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics have released a joint position statement on diabetes self-management education and support (DSME/S) for patients with type 2 diabetes. The statement provides an algorithm to guide providers on when to refer patients for education and support, and highlights 4 critical times for assessing the need for DSME/S: at patient diagnosis; annually; when new disease complications affect disease management; and, when transitions in care occur. You can follow this link to read a segment of the document (subscription required to download the full document) or click here to read an ADA press release with more details on this statement.
Biomarkers Related to Severe Hypoglycemia and Lack of Good Glycemic Control in ACCORD
Biomarkers Related to Severe Hypoglycemia and Lack of Good Glycemic Control in ACCORD
June 2015. This study was developed to identify blood biomarkers that predict the success of glycemic control intensification in patients with type 2 diabetes. Investigators used a nested, case-control design to compare case (n=326) and control (n=1075) patients using data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study. Cases comprised patients with severe hypoglycemia who failed to reach an A1C level <6.0% before the ACCORD study transition or death, while control patients did not have severe hypoglycemia and had A1C levels <6.0%. Baseline insulin deficiency and islet autoantibody biomarkers (fasting C-peptide, glutamic acid decarboxylase, tyrosine phosphatase-related islet antigen 2, insulin, and zinc transporter 8) were measured and compared using conditional logistic regression with and without adjustment for age. Investigators found that severe hypoglycemia and an inability to reach target A1C was associated with insulin deficiency, all measured autoantibodies, or patient baseline insulin use. You can follow this link to download the full article.
Veterans Affairs Diabetes Trial: Follow-up of Glycemic Control and Cardiovascular Outcomes in Type 2 Diabetes
June 4, 2015. Previously, the 5.6-year Veterans Affairs Diabetes Trial (VADT) found that intensive glucose lowering did not significantly reduce the rate of major cardiovascular (CV) events compared with standard therapy in patients with type 2 diabetes (T2D). This publication reports on the extended follow-up of VADT participants over a median of 9.8 years, with data available for 92.4% of patients. The primary outcome was time to the first major CV event; secondary outcomes were CV mortality and all-cause mortality. Investigators found that the intensive therapy group had a significantly lower risk of the primary outcome than the standard-therapy group (hazard ratio [HR], 0.83; P=0.04), with an absolute risk reduction of 8.6 major CV events per 1000 person-years. However, these patients did not experience reduced CV or total mortality. You can click here to read the study abstract.
Evaluation of Lixisenatide in Acute Coronary Syndrome Study – American Diabetes Association Scientific Sessions
June 9, 2015. Clinical trial results for the ELIXA study (Evaluation of Lixisenatide in Acute Coronary Syndrome) were presented at the American Diabetes Association 75th Annual Scientific Sessions. This multi-country, multisite study evaluated over 6,000 patients with type 2 diabetes (T2D) who had experienced an acute coronary syndrome event in the 180 days before enrollment. This study was designed to meet the US Food and Drug Administration’s 2008 requirement for cardiovascular safety studies for T2D drugs; lixisenatide is the first glucagon-like peptide-1 inhibitor drug to be evaluated in such a study. Primary endpoints were cardiac death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for unstable angina. Investigators reported that outcomes were similar for lixisenatide and placebo; that is, lixisenatide did not provide cardiovascular protection but was also not associated with increased risk. Additionally, no increased risk of pancreatitis or pancreatic cancer was observed with lixisenatide. You can follow this link to read a media summary of the ELIXA study and its results.
Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes
June 9, 2015. Results of the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) study were simultaneously presented at the American Diabetes Association 75th Annual Scientific Sessions and published online by the New England Journal of Medicine. This randomized, double-blind study evaluated 14,671 patients with type 2 diabetes and established cardiovascular (CV) disease who added sitagliptin or placebo to their existing therapeutic regimen. The primary CV outcome was a composite of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. A relative risk of 1.3 was applied as the upper boundary for confirming sitagliptin’s non-inferiority vs placebo. Over a median 3-year of follow-up, the primary outcome occurred in 11.4% (n=839) of sitagliptin patients and 11.6% (n=851) of placebo patients. Sitagliptin was non-inferior to placebo for the composite CV endpoint. A small difference in A1C levels (0.29%) was observed for patients receiving sitagliptin vs placebo. You can click here to download the full TECOS study publication.
Results Presented for the Fluctuation Reduction With Insulin and GLP-1 Added Together (FLAT-SUGAR) Trial
June 9, 2015. Results of the Fluctuation Reduction With Insulin and Glucagon-like Peptide-1 agonist (GLP-1) Added Together (FLAT-SUGAR) trial were presented at the American Diabetes Association 75th Annual Scientific Sessions. This trial was developed to assess the severity and impact of glucose variability (assessed using masked continuous glucose monitoring [CGM]), on cardiovascular (CV) risk in middle-aged and older patients with type 2 diabetes and additional CV risk factors. The FLAT-SUGAR trial enrolled 102 patients receiving background therapy with basal insulin (glargine) and metformin. Patients were then randomized to add-on therapy with the GLP-1 agonist exenatide or a rapid-acting insulin analogue (aspart, glulisine, or lispro). The primary study outcome was to compare CV risk factor changes by assessing the coefficients of variation (CoV) in patient CGM readings. Mean baseline CoV was 31.9 for patients who added the GLP-1 to their regimen and 30.3 for patients who added rapid-acting insulin. At 26 weeks, CoV decreased by 2.4 for the GLP-1 group and increased by 0.4 for the rapid-acting insulin group. Patients in the GLP-1 group also experienced greater weight loss and decreased serum amyloid A and alanine aminotransferase levels. Investigators also found that the mean amplitude of glycemic excursions was improved in the GLP-1 group (P=0.049); however, no other significant results were observed in measures of glycemic variability. No severe hypoglycemia was reported for either group. You can follow this link to read a media summary of these study results.
Adding Dapagliflozin to Insulin and Liraglutide Leads to Significant Improvements in Glycemic Control in Patients With Type 1 Diabetes
May 18, 2015. Results of a retrospective analysis evaluating the impact of triple therapy with insulin, liraglutide, and dapagliflozin in patients with type 1 diabetes were presented at the 24th Annual American Association of Clinical Endocrinologists Scientific and Clinical Congress. This retrospective analysis evaluated the impact of adding dapagliflozin therapy to 10 patients already receiving liraglutide plus insulin. Dapagliflozin was initiated at a daily dose of 5 mg and increased to 10 mg over approximately 1 week; results were evaluated after 12 weeks of triple therapy. Patients had a baseline A1C of 8%. At study end, mean A1C levels fell by 0.66% ± 0.22% (P=0.0004). Additionally, patients’ total insulin dose remained unchanged, and no increased rates of hypoglycemia were observed; however 1 patient with normal blood glucose concentrations developed diabetic ketoacidosis within 48 hours of increasing the dapagliflozin dosage. To read the full study abstract, follow this link to page 8, abstract #1213.
FDA Drug Safety Communication: SGLT2 Inhibitors for Diabetes May Result in Ketoacidosis
May 15, 2015. The US Food and Drug Administration (FDA) is warning that the sodium-glucose cotransporter-2 (SGLT2) inhibitors canagliflozin, dapagliflozin, and empagliflozin, used to treat type 2 diabetes, may lead to ketoacidosis. Patients should seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Health care professionals should evaluate patients who present with these signs or symptoms and discontinue SGLT2 inhibitors if acidosis is confirmed. The FDA will continue to investigate this issue to determine if any changes are required to these SGLT2 inhibitors’ prescribing information. You can read the full FDA press release here.
Asian Indians Show High Incidence of Diabetes and Rapid Progression
April 23, 2015.This article evaluated the incidence of diabetes and prediabetes and the rates and predictors of dysglycemic progression in a population-based Asian Indian cohort (the Chennai Rural Epidemiology Study). At baseline, diabetes, prediabetes, and “any dysglycemia” incidence were 22.2, 29.5, and 51.7 per 1,000 person-years, respectively. Over a median 9.1 years of follow-up, 19.4% of individuals with normal glucose tolerance converted to diabetes and 25.7% to prediabetes. Among individuals with baseline prediabetes, 58.9% converted to diabetes. The primary predictors of disease progression were older age, family history of diabetes, elevated 2-hour plasma glucose and A1C levels, low HDL cholesterol, and physical inactivity. Investigators noted that this Asian Indian population has one of the highest diabetes incidence rates worldwide, with an extremely rapid conversion from normoglycemia to hypoglycemia. You can read the study abstract at this link.
Effect of the Threshold Suspend Feature for Insulin Delivery on Hypoglycemia
April 15, 2015. This study evaluated sensor glucose (SG) data from 20,973 patients who enabled the automatic threshold suspend (TS) feature of the MiniMed 530G system and uploaded their pump and sensor data. When enabled, TS suspends insulin delivery for up to 2 hours when SG values reach a prespecified threshold. A comparison was made based on patient-days where TS was enabled (n=758,382) vs not enabled (166,791). Additionally, data from patients who always enabled the sensor (n=14,673) were compared with those who never enabled the feature (2,249), as was recovery from hypoglycemia before and after TS use. Investigators found that, when enabled, the TS feature consistently reduced hypoglycemic exposure (62% to 69% fewer events of blood glucose ≤50 mg/dL), with a pronounced effect at nighttime. You can follow this link to read the full article.
Diabetes Drug (Liraglutide) Makes NASH Vanish in Some Patients
April 23, 2015. Research findings presented at the 2015 International Liver Conference In Vienna indicate that treating patients with injectable liraglutide provides substantial clinical response and reduced fibrosis in patients with nonalcoholic steatohepatitis (NASH). In this double-blind, randomized trial, 52 patients with obesity and biopsy-demonstrated NASH were assigned to receive once-daily injections of liraglutide 1.8 mg or placebo. After the 48-week treatment, 45 patients underwent liver biopsy; of these, 39% (9/23) who received liraglutide had resolved NASH vs 9% of patients receiving placebo. Two liraglutide patients experienced worsening fibrosis vs 8 with placebo. Liraglutide patients also experienced weight loss and improved fasting glucose compared with placebo. You can link to the study abstract here (see page 11, presentation G01) or click here to read a media summary of the study presentation.
US Centers for Disease Control and Prevention Announces Prediabetes Initiative
April 23, 2015. The US Centers for Disease Control is working with the American Medical Association to encourage physicians to recruit Americans living with prediabetes into evidence-based prevention programs to decrease their risk of progression to type 2 diabetes. The initiative is called “Prevent diabetes STAT: Screen, Test, Act—Today™.” Two measurable goals have been proposed: that participants lose at least 7% of their body weight—and keep it off—and increase physical activity to at least 150 minutes a week. You can read the full announcement, published in The Lancet at this link.
FDA Panel Backs Safety Updates for Saxagliptin and Alogliptin
April 14, 2015. An advisory committee to the U.S. Food and Drug Administration (FDA) has indicated that the labels for the dipeptidyl peptidase-4 inhibitor drugs saxagliptin and alogliptin should carry information about the potential risk of heart failure (HF) with these medications. This recommendation was based on information obtained from long-term cardiovascular follow-up studies, which found that neither drug was associated with an increased risk of overall cardiovascular death, stroke, or myocardial infarction. However, a significantly increased HF risk was observed with saxagliptin, and a numeric but not statistically significant increase was observed with alogliptin. The FDA is not required to follow the input of its advisory boards, but it generally does so. Click here to read a media summary of this story.
Screening for Type 2 Diabetes Mellitus: A Systematic Review for the U.S. Preventive Services Task Force
April 14, 2015. This document provides an update to the 2008 U.S. Preventive Services Task Force review on diabetes screening in adults. Following a comprehensive literature review, investigators found that available data suggest no 10-year mortality benefit to accompany diabetes screening. Additionally, trials of patients with impaired glucose tolerance and/or impaired fasting glucose indicate that treating these conditions is associated with reduced progression to type 2 diabetes. However, only one study found a link between pre-diabetes treatment and overall mortality or cardiovascular mortality; this study evaluated a lifestyle intervention, not medication, over a 23-year period. You can follow this link to download a full copy of the article.
American Association of Clinical Endocrinologists/American College of Endocrinology Release New, Comprehensive Clinical Practice Guidelines and Updated Algorithm for Developing a Comprehensive Diabetes Mellitus Care Plan
April 2015. AACE/ACE announced the publication its new diabetes clinical practice guidelines and updated diabetes algorithm to assist clinical caregivers with the medical management of patients with diabetes mellitus. These substantially modified guidelines advocate for comprehensive diabetes control beyond glycemic control, addressing multiple risk factors. The AACE/ACE guidelines promote individual patient goals and the development of personalized management plans. To that end, comprehensive clinical recommendations are offered for assessing and managing obesity, lipid disorders, hypertension, kidney disease, cardiovascular disease, hypoglycemia, and antihyperglycemic therapy. Follow this link to download the full guidelines document.
The Effect of Dapagliflozin on Glycemia and Cardiovascular Risk Factors in High-Risk Patients With Type 2 Diabetes
April 7, 2015. This multicenter, randomized, double-blind, placebo-controlled trial was developed to assess the efficacy and safety of dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, vs placebo over 24 weeks, with a 28-week extension period. Patients (N=922) had type 2 diabetes, preexisting cardiovascular disease, and a history of hypertension; they were allocated to treatment with dapagliflozin 10 mg or placebo. Among patients receiving insulin, the dose was reduced by 25% at randomization. The trial had 2 primary endpoints: A1C reduction from baseline and a combined reduction of A1C (≥0.5%), body weight (≥3%), and systolic blood pressure (≥3 mm Hg). Compared with placebo, significantly more patients achieved both endpoints; results were similar regardless of patient age. Certain adverse events (including hypotension, genital infection, and renal failure/impairment) occurred more often in patients receiving dapagliflozin. You can follow this link to read the study abstract.
Insulin Pump Risks and Benefits: A Clinical Appraisal of Pump Safety Standards, Adverse Event Reporting, and Research Needs
April 2015. The European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) Diabetes Technology Working Group have published a joint statement on the topic of insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII). Because available evidence on the safety and efficacy of CSII remains limited, the EASD and ADA have collaborated to review systems in place for evaluating pump safety from a clinical perspective. Topics addressed include the need for insulin pump manufacturers to share internal data, problems with the US Food and Drug Administration’s Manufacturer and User Facility Device Experience database, and a call for additional observational studies and clinical trials (in particular, long-term, real-world research) to evaluate these devices. You can follow this link to read the full document.
Gender-Based Differences in Glycemic Control and Hypoglycemia Prevalence in Patients With Type 2 Diabetes
March 20, 2015. This study evaluated the impact of gender on glycemic control and hypoglycemia using pooled data from 6 randomized clinical trials of insulin glargine or NPH insulin in insulin-naïve patients with type 2 diabetes. Both males and females had similar baseline A1C levels and diabetes duration (~8.9% and ~10 years) and were followed for 24-36 weeks following insulin initiation. Over time, men experienced a significantly greater A1C reduction compared with women (-1.36% vs -1.22, P=0.002), and at trial end, women required a significantly higher insulin dose than men (0.47 vs 0.42 U/kg; P<0.001). Additionally, the incidence rates of severe and severe nocturnal hypoglycemia were significantly higher in women than men (respectively, 3.28% vs 1.85%, P<0.05; and 2.24% vs 0.59%, P<0.001). The authors concluded that, to optimize glycemic control and hypoglycemia risk, clinicians should carefully monitor insulin dosing, particularly in female patients. You can read the full study abstract here.
2 Treatment Approaches for Human Regular U-500 Insulin in Patients With Type 2 Diabetes Not Achieving Adequate Glycemic Control on High-Dose U-100 Insulin Therapy With or Without Oral Agents: A Randomized, Titration-to-Target Clinical Trial
March 26, 2015. This 24-week, open-label, parallel trial compared the efficacy and safety of 2 dosing regimens of human regular U-500 insulin, used to replace high-dose U-100 insulin. The patient population was 325 patients with inadequately controlled type 2 diabetes (T2D). At baseline, mean patient A1C was 8.7%, and U-100 insulin dose was 287.5 units administered over 5 daily injections. Patients were randomized to treatment with twice- or thrice-daily U-500R (BID, TID); the primary outcome was A1C reduction from baseline. At 24 weeks, both treatments showed clinically equivalent A1C reductions that were statistically significant from baseline (BID -1.22%, TID -1.12%, P<0.001). Weight gain and rates of severe hypoglycemia were similar between treatment groups. Investigators indicated that these results provide a practical framework for initiating U-500R therapy in patients with severe insulin resistance and poorly controlled T2D. Click here to read the study abstract.
FDA Approves New Treatment for Diabetic Retinopathy in Patients With Diabetic Macular Edema
March 25, 2015. The U.S. Food and Drug Administration (FDA) has expanded the approved use for aflibercept injection (Eylea) to treat diabetic retinopathy (DR) in patients with diabetic macular edema. Aflibercept is administered by injection into the eye once monthly for 5 months and subsequently once every 2 months. The drug’s safety and efficacy were evaluated in 679 patients in 2 clinical studies; patients were randomly assigned to receive aflibercept or macular laser photocoagulation. At week 100, patients treated with aflibercept showed significant improvement in DR severity compared to patients who did not receive aflibercept. You can follow this link to read the FDA press release.
Dapagliflozin Lowers Plasma Glucose Concentration and Improves Beta Cell Function
March 2015. This study was designed to examine the effects of the sodium glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin on beta cell function in patients with type 2 diabetes mellitus (T2DM). Twenty-four individuals with T2DM received dapagliflozin or placebo for 2 weeks, with a 75-gram oral glucose tolerance test (OGTT) and insulin clamp performed before and after treatment. During the OGTT, plasma glucose, insulin, and C-peptide concentrations were also measured. Investigators found that dapagliflozin significantly lowered both fasting and 2-hour plasma glucose concentrations. The incremental area under the plasma C-peptide concentration curve tended to increase with dapagliflozin, but not placebo. Based on insulin clamp tests, dapagliflozin also significantly improved whole-body insulin sensitivity. These results led investigators to conclude that dapagliflozin improves insulin sensitivity, based on a predefined algorithm that incorporated these outcomes. You can follow this link to read the full study abstract.
Surge in Newly Identified Diabetes Among Medicaid Patients in 2014 Within Medicaid Expansion States Under the Affordable Care Act
March 22, 2015. Pursuant to the Affordable Care Act (ACA), 26 states and the District of Columbia expanded Medicaid in January 2014, while 24 states did not. Investigators identified the number of patients with newly identified diabetes among enrollees aged 19 to 64 years in states that expanded Medicaid vs those that did not. In the states that expanded Medicaid, the number of Medicaid-enrolled patients with newly identified diabetes increased by 23% (14,625 vs 18,020), compared with an increase of 0.4% (11,612 vs 11,653 patients) in the states that did not expand Medicaid. Results were similar regardless of patient age or gender. The investigators noted that this early identification could lead to earlier treatment and improved patient outcomes. Click here to read the full study abstract.
Efficacy and Safety of Saxagliptin in Older Participants in the SAVOR-TIMI 53 Trial
March 10, 2015. This retrospective analysis was conducted to examine the safety and cardiovascular (CV) effects of saxagliptin in elderly (≥65 years, n=8561) and very elderly (≥75 years, n=2330) patients who participated in the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus-Thrombolysis in Myocardial Infarction 53 (SAVOR-TIMI 53) trial. The primary endpoint was a composite of CV mortality, myocardial infarction, or ischemic stroke; patients were followed for a median of 2.1 years. Compared with SAVOR-TIMI 53 patients aged 40 to 64 years, the hazard ratio for the primary endpoint was 0.92 for elderly patients and 0.94 for very elderly patients, indicative of no age-related treatment interaction. All patients experienced similar A1C reductions. However, regardless of age, heart failure hospitalization risk was higher in all patients receiving saxagliptin. You can read the study abstract here.
Heart Failure and Mortality Outcomes in Patients With Type 2 Diabetes Taking Alogliptin Versus Placebo in EXAMINE
March 2015. Concerns have been reported regarding excessive rates of in-hospital heart failure (HF) with DPP-4 inhibitors. This evaluation of data from EXAMINE, a multicenter, randomized, double-blind trial, assessed HF-related hospital admission rates in patients assigned to treatment with alogliptin (n=2701) or placebo (n=2679) and followed for a median of 533 days. The endpoint was a composite of major adverse cardiac events (MACE), comprising all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, urgent revascularization due to unstable angina, and hospital admission for HF. The MACE endpoint was observed in 16.0% (433) of patients receiving alogliptin and 16.5% (441) of patients assigned to placebo; this finding was not statistically significant. The investigators concluded that alogliptin does not increase patient risk for HF-related outcomes. Follow this link to read the full study abstract.
AACE Responds to “Unmanageable” Situation, Pushes Congress to Pass Improved Diabetes Care Legislation
March 3, 2015. The American Association of Clinical Endocrinologists (AACE) is leading more than 40 national organizations representing physicians, allied health professionals, patients, communities, and the medical industry in support of legislation that will improve care for individuals with diabetes, prediabetes, and associated illnesses. The National Diabetes Clinical Care Commission Act (H.R. 1192/S. 586) calls for the creation of a commission of the country’s foremost diabetes experts—endocrinologists and related clinical care specialists, patient advocates, and federal agency representatives—to identify duplication and critical gaps in federal diabetes initiatives and make recommendations to improve diabetes care implementation and coordination. A delegation of AACE leaders will visit Congress members this week to advocate for this act and other high-priority legislative initiatives. Follow this link to read the full AACE press release.
Preventable Major Cardiovascular Events Associated With Uncontrolled Glucose, Blood Pressure, and Lipids, and Active Smoking in Adults With Diabetes With and Without Cardiovascular Disease: A Contemporary Analysis
February 20, 2015. This study assessed the incidence of major cardiovascular (CV) hospitalization events and all-cause deaths among adults with diabetes with or without cardiovascular disease (CVD), inadequately controlled A1C, elevated LDL cholesterol (LDL-C) and blood pressure (BP), and current smoking. Participants were 859,617 adults with diabetes enrolled in U.S. integrated health care organizations between 2005 and 2011 (31% with existing CVD). Mean follow-up was 59 months, and event rates per 100 person-years for adults with diabetes and CVD vs those without CVD were 6.0 vs 1.7 for myocardial infarction/acute coronary syndrome, 5.3 vs 1.5 for stroke, 8.4 vs 1.2 for heart failure, and 18.1 vs 5.0 for all-cause mortality. The percentage of CV events and deaths associated with inadequate risk factor control were 11% and 3%, respectively, for those with CVD, and 34% and 7% for those without CVD. Investigators concluded that increased attention to traditional CV risk factors might reduce negative CV outcomes and mortality in adults with diabetes. You can follow this link to read the study abstract.
Initial Combination of Empagliflozin and Linagliptin in Patients With Type 2 Diabetes
March 2015. This 52-week randomized study was conducted to evaluate the efficacy and safety of combined therapy with empagliflozin and linagliptin in patients with type 2 diabetes (T2D). Mean baseline patient A1C was approximately 8%. Following a washout period, patients (N=677) were proportionally assigned to 1 of 5 study groups (listed with A1C reductions achieved at 24 weeks): empagliflozin 25 mg/linagliptin 5 mg (-1.08%); empagliflozin 10 mg/linagliptin 5 mg (-1.24%); empagliflozin 25 mg (-0.95%); empagliflozin 10 mg (-0.83%); or linagliptin 5 mg (-0.67%). These results were statistically significant for combined empagliflozin/linagliptin treatment vs treatment with only 1 drug (with the exception of empagliflozin 25 mg, which did not significantly lower A1C levels compared with combined therapy). Investigators reported that efficacy was maintained through study end, and that these therapies were well tolerated. Please follow this link to read the full study abstract.
FDA Approves New Insulin Product, Toujeo
February 25, 2015. The U.S. Food and Drug Administration (FDA) has approved insulin Toujeo® (insulin glargine [rDNA origin] injection, 300 U/mL). Expected to be available in the United States by mid-2015, this once-daily, long-acting basal insulin has been approved to improve glycemic control in adults with type 1 and type 2 diabetes. This approval was based on FDA review of results from the EDITION clinical trial program, a series of international phase III studies evaluating the efficacy and safety of Toujeo in more than 3,500 adults with diabetes. You can read a press release regarding this approval by following this link.
A Randomized Controlled Trial to Provide Adherence Information and Motivational Interviewing to Improve Diabetes and Lipid Control
February 2015. This study assessed whether patients with medication adherence information (AI) provided to their physicians, with or without motivational interviewing (MI), was associated with improved diabetes and lipid control. Participants (N=1692) were members of a single large Michigan health system; they had A1C levels above target and were receiving oral antidiabetic and lipid-lowering medications. Patients were assigned to usual care (UC) or UC with AI or with AI + MI. The primary outcomes were A1C and LDL cholesterol levels at 18 months. Compared with UC, neither AI nor MI improved diabetes or lipid control. Investigators noted that they had difficulty encouraging patient participation in the MI study arm. You can follow this link to read the full study abstract.
Gender-Based Differences in Glycemic Control and Hypoglycemia Prevalence in Patients With Type 2 Diabetes
February 2015. This study was designed to evaluate the impact of patient gender on glucose control and hypoglycemia incidence in insulin-naïve patients with inadequately controlled type 2 diabetes (T2D). Investigators evaluated patient-level pooled data from 6 randomized controlled trials of insulin glargine or NPH insulin (N=2600; trials were 24-36 weeks duration). Mean baseline patient A1C was ~8.9%-9.0% and mean patient age was 57 years. Compared with males, significantly fewer females achieved a target A1C level of <7% (P<0.001); the observed reduction in A1C levels was -1.36% for men and -1.22% for women (P=0.002). Females also required significantly higher insulin dosage (0.47 vs 0.42 U/kg; P<0.001) and had a higher risk of severe daytime and nocturnal hypoglycemia (3.28% vs 1.85%; P<0.05 and 2.24% vs 0.59%; P<0.001, respectively). Based on these findings, the authors advised physicians to closely monitor insulin dosing in female patients to achieve glucose control with reduced hypoglycemia risk. You can read the full study abstract at this link.
FDA Approves Lucentis to Treat Diabetic Retinopathy in Patients With Diabetic Macular Edema
February 6, 2015. The U.S. Food and Drug Administration (FDA) has expanded the approved use for Lucentis (ranibizumab injection) 0.3 mg to treat diabetic retinopathy in patients with diabetic macular edema. This treatment is administered by a physician monthly via injection into the eye. You can read the full FDA press release here.
FDA Approves Empagliflozin/Linagliptin Combination for Adults With Type 2 Diabetes
February 2, 2015. The U.S. Food and Drug Administration (FDA) has approved combined empagliflozin/linagliptin tablets (Glyxambi®) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are good candidates for both drugs. The once-daily tablet combines a sodium-glucose cotransporter 2 (SGLT2) inhibitor (empagliflozin, 10 or 25 mg) with a dipeptidyl peptidase-4 (DPP-4) inhibitor (linagliptin, 5 mg). You can link here to a press release regarding this therapy, or click here to download Glyxambi’s prescribing information.
Initial Combination Treatment With Empagliflozin and Linagliptin in Patients With Type 2 Diabetes
January 29, 2015. This study randomized antihyperglycemic drug-naïve patients (N=677) with type 2 diabetes to 52 weeks of treatment with 1 of 5 regimens: empagliflozin (EMP) 25 mg + linagliptin (LIN) 5 mg; EMP 10 mg + LIN 5 mg; EMP 25 mg; EMP 10 mg; or LIN 5 mg. The primary endpoint was change in A1C from baseline to week 24; patients’ mean baseline A1C levels were 7.99% to 8.05%. At week 24, patients had the following A1C reductions: EMP 25 mg + LIN 5 mg, -1.08% (P <0.001 vs LIN 5 mg); EMP 10 mg + LIN 5 mg, -1.24% (P <0.001 vs EMP 10 mg and LIN 5 mg); EMP 25 mg, -0.95%; EMP 10 mg, -0.83%, and LIN 5 mg -0.67%. Investigators reported that combined treatment with EMP + LIN was well tolerated. You can follow this link to ready the study abstract.
Incretin-Based Therapy and Risk of Acute Pancreatitis: A Nationwide Population-Based Case-Control Study
January 29, 2015. This case control study evaluated whether the use of incretin-based drug therapy (glucagon-like peptide-1 agonists and dipeptidyl peptidase-4 inhibitors) in type 2 diabetes was associated with an elevated risk of acute pancreatitis. Data were obtained from a nationwide population-based Danish medical database (12,868 patients with a first-time hospitalization for acute pancreatitis between 2005 and 2012, and 128,680 matched controls). Investigators adjusted for a history of gallstones, alcoholism, obesity, and other comorbidities, as well as the use of medications associated with pancreatitis. Eighty-nine pancreatitis patients (0.69%) and 684 control patients (0.53%) were ever users of incretins (adjusted odds ratio 0.97 [95% confidence interval, 0.76-1.23]). The investigators concluded that the use of incretin-based drugs did not appear to be associated with an elevated pancreatitis risk. You can read the full study abstract here.
Incretin-Based Drugs and the Risk of Congestive Heart Failure
February 2015. This retrospective analysis was conducted to determine whether the use of incretin-based drugs (dipeptidyl-peptidase-4 inhibitors, glucagon-like receptor-1 analogs) was associated with an increased risk of congestive heart failure (CHF) among patients with type 2 diabetes. Data were obtained from the UK Clinical Practice Research Datalink, and patients with no prior CHF history and newly prescribed to antidiabetic drug regimens between January 1, 2007, and March 31, 2012, were evaluated. The cohort comprised 57,737 patients, with a mean 2.4 years’ follow-up. Investigators found that the use of incretin-based drugs was not associated with increased CHF risk (adjusted OR 0.85 [95% CI 0.62–1.16]). The authors also indicated that these results should be verified by large-scale studies. You can follow this link to read the study abstract.
FDA Allows Marketing of First CGM Mobile Medical Apps
January 23, 2015. The US Food and Drug Administration (FDA) has approved marketing of the first set of mobile medical apps that allow diabetes patients to automatically and securely share data from a continuous glucose monitor (CGM) in real time using an Apple mobile device such as an iPhone. The Dexcom Share Direct Secondary Displays system’s data sharing enables caregivers to monitor patient blood glucose levels via mobile devices. You can follow this link to read the full FDA press release.
Endocrine Society Releases New Obesity Drug Treatment Guidelines
January 15, 2015. The Endocrine Society has published a guideline for the pharmacologic management of obesity in patients not achieving success with diet and exercise alone. These guidelines were developed to help providers identify patients who might benefit from pharmacotherapy for obesity and provide relevant evidence and background on available pharmacologic agents. The guidelines provide recommendations on medication use and dosage, including recommendations for patients with obesity-related comorbidities such as type 2 diabetes and cardiovascular disease. The guidelines also offer specific recommendations for transitioning patients off drugs that cause weight gain. You can follow this link to review the guidelines abstract or download the full text.
FDA Label May Prevent Use of Metformin in Some Patients With Type 2 Diabetes
December 2014. Researchers from Penn Medicine and Weill Cornel Medical College have reported that many US patients with type 2 diabetes (T2D) may be discouraged from taking metformin because the US Food and Drug Administration inappropriately labels the drug unsafe for some patients with renal impairment. You can follow this link to read the research letter published in JAMA Internal Medicine (note: log-in required). Click here to read the abstract of the systematic review that triggered this research letter. You can also follow this link to read the press release from Penn Medicine.
Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical Trials
December 12, 2014. This study evaluated pooled data from Novo Nordisk–sponsored Phase 2 and 3 liraglutide trials to review acute and chronic pancreatitis (AP and CP) cases observed in the clinical trial program. All patients were receiving multiple medications. Among 6,345 patients treated with liraglutide, 8 AP cases were found; 1 AP case was identified from the 1,846 comparator-treated patients (patient was treated with glimepiride). However, 1 of 8 of the liraglutide AP cases did not meet diagnostic criteria; additionally, in 6 of 8 cases, recognized risk factors for AP were present and/or AP onset occurred >6 months after liraglutide initiation. Four cases of chronic pancreatitis (CP) were identified in liraglutide patients vs none with the comparator; however, only 1 of 4 of these cases fulfilled diagnostic criteria for CP. The investigators concluded that while pancreatitis cases were numerically higher with liraglutide, problems with diagnostic criteria and confounding variables preclude any ability to draw firm conclusions. You can follow this link to rea the study abstract.
Sulfonylurea in Combination With Insulin Is Associated With Increased Mortality Compared With a Combination of Insulin and Metformin in a Retrospective Danish Nationwide Study
January 2015. This retrospective study evaluated approximately 28,000 patients to assess whether the use of sulfonylureas + insulin vs metformin + insulin is associated with more frequent episodes of hypoglycemia and increased mortality risk. Findings indicate that sulfonylurea + insulin users have an elevated risk of hypoglycemia compared with metformin + insulin users (17-23 vs 6 events per 1,000 person-years, respectively); hypoglycemia-related mortality (rate ratio [RR] 2.13, 95% confidence interval [CI] 1.97, 2.37); overall mortality (RR 1.81, 95% CI 1.63, 2.01); and cardiovascular death (RR 1.35, 95% CI 1.14, 1.60). No significant differences in outcomes were observed based on sulfonylurea type. The article can be downloaded in full from the Diabetologia homepage; follow this link and scroll to the middle of the page for the article summary and full link.
American Diabetes Association Releases 2015 Standards of Care
December 23, 2014. The American Diabetes Association’s (ADA’s) annual Standards of Medical Care in Diabetes has been released. Key updates include the following: Individuals with diabetes should limit sedentary time by breaking up extended amounts of time (>90 minutes) spent sitting. People with diabetes should engage in resistance training at least twice a week (unless this is not possible due to other medical reasons). The ADA has revised premeal blood glucose targets to reflect new data; the new target is 80 mg/dL to 130 mg/dL. The recommended diastolic blood pressure goal for most people with diabetes and hypertension was changed from 80 mm Hg to 90 mm Hg. Additionally, the body mass index cut point for screening Asian patients for diabetes has been changed to 23 kg/m2 (from 25 kg/m2). Last, the 2015 standards bring the ADA in line with the American College of Cardiology and American Heart Association in terms of statin use; low- or high-dose statins are recommended for all people at risk for heart disease, including those with diabetes. While the supplement is considered a single document, it is now divided into 14 individual, downloadable sections. You can follow this link to download the 2015 ADA Standards; alternately, follow this link to a summary of revisions made to the 2015 standards.
FDA Approves Liraglutide for Weight Management
December 23, 2014. The U.S. Food and Drug Administration (FDA) has approved Novo Nordisk’s injectable diabetes drug liraglutide (trade name, Saxenda) for chronic weight management in adults with a body mass index (BMI) of ≥30 kg/m2 or with a BMI of ≥27 kg/m2 and at least one weight-related medical condition. Follow this link to read the full FDA press release.
Possible Adverse Effects of SGLT-2 Inhibitors on Bone (Commentary)
December 15, 2014. A commentary in the current issue of The Lancet reviews evidence for an association between the use of sodium glucose cotransporter-2 (SGLT2) drugs and an increase in treatment-emergent bone fractures. Clinical trials have shown that this drug class is effective in lowering glucose and in weight loss; however, these benefits need to be balanced against possible side effects. No Medline abstract for this commentary is available; you can read a brief summary at The Lancet’s website
First Set of Interoperability Standards for Diabetes Devices Released
December 11, 2014. The JDRF and the Centre for Global eHealth Innovation at the University Health Network in Toronto have published the first set of interoperability standards to enable intercommunication between diabetes devices (such as blood glucose monitors, insulin pumps, and continuous glucose monitors) and other media. Inter-device connectivity has been a challenge because product manufacturers typically develop proprietary communications systems. These new standards set a definition for interoperability between devices and external computers, with the goal of establishing consistent protocols and a universal understanding of device data. You can follow this link to read a press release regarding the new interoperability standards. There is also a link to purchase the published standards.
Is There a Link Between Liraglutide and Pancreatitis? A Post Hoc Review of Pooled and Patient-Level Data From Completed Liraglutide Type 2 Diabetes Clinical Trials
December 12, 2014. This study evaluated phase 2 and 3 research conducted by Novo Nordisk to determine the incidence of acute or chronic pancreatitis (AP/CP) in patients receiving liraglutide or comparator drugs. Using data representing >8,000 patient-years, 8 AP cases were identified in liraglutide patients (7 of which met diagnostic criteria for AP), and 1 with the comparator drug glimepiride. Additionally, 4 CP cases were identified with liraglutide (1 of which met diagnostic criteria for CP) and none with comparators. The investigators concluded that pancreatitis incidence was numerically greater with liraglutide vs comparators; however, a high prevalence of confounding variables, as well as issues with diagnostic criteria, prevent any firm conclusions at this time. You can read the study abstract here.
Hypoglycemia and Risk of Cardiovascular Disease and All-Cause Mortality in Insulin-Treated People With Type 1 and Type 2 Diabetes: A Cohort Study
December 9, 2014. This retrospective cohort study assessed a nationally representative population to determine whether any association exists between hypoglycemia, cardiovascular (CV) events, and all-cause mortality in insulin-using patients with type 1 or type 2 diabetes (T1D/T2D). The investigators found that, regardless of whether or not patients had a history of CV disease, hypoglycemia was significantly and persistently associated with increased risk for all outcomes. Hazard ratios (HRs) for CV disease in patients with T1D were 1.51 and 1.61 for those with and without CV disease history, respectively; for patients with T2D, these respective HRs were 1.60 and 1.49. For all-cause mortality, respective HRs were 1.98 and 2.03 for T1D and 1.74 and 2.48 for T2D. For all patients, the median time from an initial hypoglycemic event to a first CV event was 1.5 years. You can follow this link to read the study abstract.
Pioglitazone and Bladder Cancer Risk: A Multipopulation Pooled, Cumulative Exposure Analysis
December 2014. This study evaluated several international cohorts to assess the effect of pioglitazone exposure on bladder cancer risk. Accurately assessing this risk has been difficult because of the potential for allocation bias (ie, the likelihood that patients prescribed or not prescribed pioglitazone might differ in their preexisting susceptibility to bladder cancer). To address this, the investigators applied a discrete time failure analysis using Poisson regression to model the effect of cumulative drug exposure, with time-dependent adjustment for pioglitazone use, with data subsequently pooled using fixed and random-effects meta-regression. Investigators found no evidence for an association between cumulative pioglitazone exposure and bladder cancer risk in men or women (rate ratios [RR] of 1.01 and 1.04, respectively). The authors also found no association between rosiglitazone use and bladder cancer risk (RR 1.01 and 1.00 for men and women, respectively). Follow this link to the Diabetologia website to download the full article (scroll down to the “In the News” section).
US Food and Drug Administration Approves Second Pump-Sensor Combination
December 1, 2014. The US Food and Drug Administration has approved the Animas® Vibe™, an integrated insulin pump and continuous glucose monitor (CGM) system, for insulin-dependent patients with diabetes aged ≥18 years. This is the second CGM-enabled insulin pump to come to market (Medtronic MiniMed was approved in April 2006). Please follow this link to read a relevant press release from the product manufacturer.
The Economic Burden of Elevated Blood Glucose Levels in 2012: Diagnosed and Undiagnosed Diabetes, Gestational Diabetes Mellitus, and Prediabetes
December 2014. This article updates prior estimates of the economic burden of diagnosed, undiagnosed, and gestational diabetes, as well as prediabetes, using retrospective 2010-2012 data obtained from the Medicare Standard Analytical Files, the Optum database, and the Nationwide Inpatient Sample. Investigators found that the annual economic burden associated with diabetes exceeded $322 billion in 2012: $244 billion of this comprised excess medical costs and $78 billion was due to reduced productivity. This national estimate was 48% higher than the 2007 estimate of $218 billion. You can follow this link to review or download the full study.
Diabetes, Antidiabetic Medications, and Pancreatic Cancer Risk: An Analysis From the International Pancreatic Cancer Case-Control Consortium
October 2014. This analysis evaluated data from 15 case-control studies from the Pancreatic Case-Control Consortium (8,305 cases, 13,987 controls) to determine: the magnitude of pancreatic cancer risk in type 2 diabetes (T2D), the time-risk relationship, and the impact of antidiabetic medications. Investigators found a 30% excess risk of pancreatic cancer in T2D patients that persisted for ≥2 decades after diagnosis, suggesting a causal relationship. Oral antidiabetic drugs were associated with significantly decreased pancreatic cancer risk (odds ratio [OR]:0.31). Short-term insulin use (<5 years) was associated with significantly higher pancreatic cancer risk (OR: 5.6), but this risk did not persist with long-term (≥15 years) use (OR: 0.95, confidence intervals not statistically significant). You can follow this link to read the full study abstract.
Effect of Hypoglycemia on Brain Structure in People With Type 2 Diabetes: Epidemiological Analysis of the ACCORD-MIND MRI Trial
December 2014. This study was designed to assess the effect of severe hypoglycemia related to type 2 diabetes (T2D) treatment on brain structure, specifically abnormal white matter (AWM) volume and total brain volume (TBV). Participants were recruited from the Action to Control Cardiovascular Risk in Diabetes-Memory in Diabetes (ACCORD-MIND) trial. Patients with ≥1 hypoglycemic event requiring assistance (n=28 of 503) were evaluated by standardized magnetic resonance imaging at baseline and 40 months. Investigators found no significant increase in AWM and only marginally significant decreases in TBV in patients who experienced hypoglycemia. The authors concluded that hypoglycemia related to T2D treatment may not substantially affect brain pathology. You can follow this link to read the full study abstract.
Dietary Intervention in Patients With Gestational Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Clinical Trials on Maternal and Newborn Outcomes
December 2014. This systematic review and meta-analysis of randomized clinical trials was conducted to evaluate the role of dietary intervention in maternal and newborn outcomes in pregnancies complicated by gestational diabetes (GD) or hyperglycemia. Nine studies (N=884) were eligible for inclusion and evaluated the following diet types: low glycemic index, total energy restriction, low carbohydrate, and others. Investigators found that a low glycemic index diet was the most appropriate intervention in this population; compared with control diets, this approach was associated with reduced insulin use and lower infant birth weight. You can read the full study abstract here.
National Institutes of Health’s National Diabetes Education Program Issues Guiding Principles for Diabetes Care
November 12, 2014. The National Institute of Health’s National Diabetes Education Program has published a new document, “Guiding Principles for the Care of People With or at Risk for Diabetes.” This document details a set of 10 guiding principles related to diabetes prevention and management, including the following topics: “Identify People With Undiagnosed Diabetes or Prediabetes,” and “Manage Prediabetes to Prevent or Delay the Onset of Diabetes.” The principles were developed to help clinicians by clarifying areas of agreement across multiple diabetes guidelines. More than a dozen federal agencies and professional organizations (including the American Association of Clinical Endocrinologists) support this document. Click here to download or review to the full document; you can click here to read the NIH’s press summary regarding this document.
Type 2 Diabetes and Cardiovascular Disease Incidence: A Cohort Study of 1.9 Million People
November 11, 2014. This large, United Kingdom-based cohort study evaluated 1,921,260 individuals to determine the association between type 2 diabetes (T2D) and 12 initial manifestations of cardiovascular disease (CVD). The investigators found that peripheral arterial disease was the most common early manifestation of CVD in patients with T2D (hazard ratio [HR] 2.98). Other CVD manifestations significantly associated with T2D were ischemic stroke (HR 1.72), stable angina (1.62), heart failure (1.56), and nonfatal myocardial infarction (1.54). You can follow this link to read the study abstract.
Superior Glycemic Efficacy With Dapagliflozin vs Glipizide in T2DM With Poor Glycemic Control on Metformin Alone
November 2014. This 52-week, randomized, double-blind study evaluated dapagliflozin vs glipizide as add-on therapies to metformin. The study included a double-blind extension period, and data up to 104 weeks are reported in this paper. Initially, glipizide treatment led to decreased A1C levels vs dapagliflozin; however, at study end, A1C reductions with dapagliflozin were -0.18% vs glipizide, and patients treated with dapagliflozin lost -5.1 kg more weight vs glipizide and reduced systolic blood pressure by -3.9 mmHg over glipizide. They also had a 10-fold lower rate of hypoglycemic events. Glipizide use was associated with weight gain and increased blood pressure. Patients taking dapagliflozin experienced higher rates of genital and urinary tract infections. To read the full study abstract, follow this link.
Competitive Accuracy of 3 Blood Glucose Monitoring Systems That Communicate With an Insulin Pump
November 2014. Published in Endocrine Practice, this study compared the accuracy of 3 blood glucose monitoring systems capable of communicating wirelessly with an insulin pump: the Contour® Next Link; OneTouch® UltraLink®; and the Nova Max Link™. The primary endpoint was accuracy across the full glucose testing range (34 to 561 mg/dL). Secondary analyses evaluated low (≤80 mg/dL) and high (>180 mg/dL) glucose ranges, as well as mean absolute relative difference. Across the entire tested range, investigators found that the Contour® Next Link had significantly better accuracy than the other 2 devices. You can follow this link to read the abstract or full article.
ADA, AACE, EASD, and ES Release Joint Statement Regarding Diabetes Publication Practices
November 2014.The American Diabetes Association, American Association of Clinical Endocrinologists, European Association for the Study of Diabetes, and the Endocrine Society have released a Joint Statement of Principal on the topic of diabetes publication practices. The full text of this statement is: “We, as representatives of scientific organizations devoted to improving health care and advancing research, reaffirm that it is the mission of our respective medical journals to report and disseminate data from scientific investigation, evolving medical care, and innovative treatments. We believe these reports serve to unite basic scientists, clinical investigators, and medical professionals regardless of their country of origin, ethnic group, or political leaning. We believe that these efforts achieve the common goal of advancing scientific discoveries that lead to improved health of people worldwide. On the basis of our goals and principles, our respective journals will refrain from publishing articles addressing political issues that are outside of either research funding or health care delivery.” You can link here to a .pdf version of the statement.
AACE Advocates for 2 Diabetes Bills Before Congress
October 20, 2014. The American Association of Clinical Endocrinologists (AACE) has presented a letter to the US Congress pressing for diabetes-related legislation. The letter calls for the passage of two bills: the Medicare Continuous Glucose Monitoring Access Act and the National Diabetes Clinical Care Commission Act. AACE is also asking Congress to hold hearings to evaluate the US Food and Drug Administration’s pre- and postmarketing surveillance and enforcement activities for medical devices and is calling for a review of Medicare’s competitive bidding practices. You can follow this link to read AACE’s letter to Congress.
Patients Using Metformin Have Increased Survival Compared With Nondiabetic Controls
November 2014. This retrospective observational study evaluated whether all-cause mortality is higher in patients with type 2 diabetes (T2D) treated with either sulfonylurea or metformin vs matched, untreated patients without diabetes. Overall, 78,241 patients receiving metformin, 12,222 receiving sulfonylureas, and 90,463 nondiabetic matched patients (representing 503,384 follow-up years) were evaluated. Progression to all-cause mortality was analyzed using parametric survival models, with T2D patients receiving metformin serving as the reference group. Investigators found that adjusted median survival time was 38% lower for sulfonylurea patients and 15% lower for nondiabetic patients. The authors noted that these finding reinforce current recommendations for metformin as first-line therapy in T2D, highlight the possible risks associated with sulfonylureas, and indicate that metformin may be associated with independent benefits. To read the full study abstract, follow this link.
Sulfonylurea Use and Incident Cardiovascular Disease Among Patients With Type 2 Diabetes: Prospective Cohort Study Among Women
November 2014. Because inconsistent evidence exists regarding the relationship between cardiovascular risk and sulfonylurea use in patients with type 2 diabetes (T2D), this study prospectively evaluated this association using data from the Nurses’ Health Study. A total of 4,902 women (mean age 68 years, mean diabetes duration 11 years; no patients had cardiovascular disease at baseline) were followed for up to 10 years. Investigators found that long-term sulfonylurea use was associated with an increased risk of coronary heart disease (P = 0.002 for trend). The relative risk for coronary heart disease among patients receiving sulfonylurea therapy over 1-5, 6-10, and >10 years, respectively, was 1.24, 1.51, and 2.15 (compared to patients who did not use sulfonylureas). You can follow this link to read the full study abstract.
A Position Statement of the American Diabetes Association: Care of Young Children With Diabetes in the Child Care Setting
October 2014. The American Diabetes Association (ADA) has released a position statement on the care of young children with diabetes in child care settings. This statement was drafted in recognition of a lack of diabetes management guidance in day care settings. It focuses primarily on young people with type 1 diabetes—the predominant diabetes diagnosis in this age group. The ADA states that these children can be safely cared for by child care providers who have received appropriate training and have access to needed resources, including an effective communication system with the child’s parents and healthcare provider. As part of this statement, the ADA has developed a sample diabetes child care management plan, as well as other resources and tools available online at http://www.diabetes.org/childcare. You can download a full copy of the Position Statement by following this link.
EDITION 2 Study: Insulin Glargine 300 Units/mL vs Glargine 100 Units/mL in People With Type 2 Diabetes
September 5, 2014. This 6-month, multicenter, open-label, 2-arm study evaluated glucose control and hypoglycemia in adults (n=811) with type 2 diabetes (T2D) receiving insulin glargine 300 U/ml/day vs glargine 100 U/ml/day alongside treatment with oral agents and basal insulin. The primary endpoint was the change in A1C levels; a secondary endpoint was the percentage of participants with ≥1 confirmed cases of nocturnal hypoglycemia (≤70 mg/dL) or severe hypoglycemia. Investigators found that both glargine formulations were equally effective in terms of glucose control, with each leading to A1C reductions of approximately -0.6%. However, glargine 300 was associated with a significantly lower rate of nighttime and overall hypoglycemic events vs glargine 100 (hazard ratio: 0.77; 95% CI 0.61-0.99). To read the full study abstract, follow this link.
ADVANCE Trial: Follow-up of Blood-Pressure Lowering and Glucose Control in Type 2 Diabetes
October 9, 2014. The factorial trial, Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE), found that combination therapy with the blood pressure-lowering medications perindopril and indapamide reduced mortality in patients with type 2 diabetes (T2D), but that intensive glucose control (A1C target <6.5%) did not. This study reports on a subsequent 6-year follow-up of surviving ADVANCE participants (n=8494) and evaluated the primary endpoints of death from any cause and major macrovascular events. Investigators found that mortality benefits persisted in an attenuated form in patients previously treated with perindopril-indapamide (hazard ratios of 0.91 [P=0.03] and 0.88 [P=0.04] for death from any cause and cardiovascular death, respectively). There were no observable long-term effects of prior intensive glucose control. You can follow this link to read the study abstract.
Randomization to a Low-Carbohydrate Diet Improves Health-Related Quality of Life Compared With a Low-Fat Diet With Similar Weight-Loss in Patients With Type 2 Diabetes
September 21, 2014. This study compared the 2-year impact of a low-fat vs low-carbohydrate diet in 61 patients with type 2 diabetes (baseline mean body mass index 32.7 kg/m2). At 6 months, both patient groups had similar weight loss (~4 kg); this was sustained for the duration of the trial. At 6 months, patients receiving the low-carbohydrate intervention experienced improved ratings on the SF-36 questionnaire physical function component. By 12 months, low-carbohydrate patients showed improvements in the measure’s physical function, bodily pain, and general health score components, with no significant changes in SF-36 component scores for the low-fat diet group at any time. Clicking this link will take you to the study abstract.
Liraglutide and the Preservation of Pancreatic Beta-Cell Function in Early Type 2 Diabetes
September 23, 2014. This 48-week, double-blind, randomized, placebo-controlled trial evaluated whether liraglutide preserved beta-cell function in patients (N=51) with type 2 diabetes (T2D) diagnosed a mean of 2.6 years previously. Because clinical studies of beta-cell function can be compromised by an inability to estimate baseline glucose function, patients in this trial were provided with short-term intensive insulin therapy to eliminate glucotoxicity before randomization. The primary outcome was performance on an oral glucose tolerance test known as the Insulin Secretion-Secretory Index-2 (ISSI-2), evaluated every 12 weeks. At 48 weeks, baseline-adjusted ISSI-2 was significantly higher in the liraglutide vs placebo group. These beneficial effects were lost within 2 weeks of stopping liraglutide treatment. You can follow this link to read the study abstract.
Weight-Loss Therapy in Type 2 Diabetes: Effects of Phentermine and Topiramate Extended-Release
September 23, 2014. This study evaluated the safety and efficacy of phentermine/extended- release topiramate (PHEN-TPM ER) treatment for obesity (alongside lifestyle modification) in 2 clinical trials of patients with type 2 diabetes (T2D). Results from two 56-week studies were evaluated: OB-202/DM-230 (N=130) and CONQUER (subpopulation analysis, n=388). In OB-202/DM-230, weight loss at 56 weeks was -9.4% for PHEN-TPM ER and -2.7% for placebo. In both trials, patients achieved their A1C targets with a reduced need for glucose-lowering medications compared with placebo-treated patients. Click this link to read the study abstract.
AACE Holds Glucose Monitoring Consensus Conference in Washington, DC
September 28-29, 2014. The American Association of Clinical Endocrinologists and key diabetes stakeholders met in Washington, DC, on September 28 and 29 to identify key concerns and priorities related to blood glucose monitoring quality, safety, and access. AACE brought together key diabetes stakeholders representing the fields of science and medicine, the pharmaceutical and device industry, and regulatory and insurance professionals, as well as patients with diabetes, to examine critical factors such as regulatory challenges, post-FDA-approval monitoring of glucose strip safety and accuracy, glucose sensors and devices, patient access, and economic/reimbursement issues. Follow this link to visit the AACE online newsroom to view the media kit prepared for this conference. To read an online summary of the conference proceedings from from Healio, link here. You can also read this summary of a statement released after the conference by AACE President R. Mack Harrell here.
AACE/ACE Final Document Publication: Consensus Conference on Obesity: Building an Evidence Base for Comprehensive Action
September 24, 2014. This month in Endocrine Practice, the American Association of Clinical Endocrinologists and American College of Endocrinology have published their final document summarizing the outcomes of the March 2014 obesity conference. This document, “Consensus Conference on Obesity: Building an Evidence Base for Comprehensive Action,” outlines key conference findings, including: the need for a medically meaningful and actionable diagnosis of obesity; research that evaluates and refines a complications-centric clinical approach to obesity; the need for a better understanding of reimbursement mechanisms and the value associated with obesity prevention and management; increased nutrition and obesity education; and, enhanced public awareness and health literacy. You may follow this link to download the full manuscript.
FDA Approves First Glucose Meter With Insulin Calculator
September 17, 2014. The U.S. Food and Drug Administration (FDA) has approved the Accu-Chek Aviva Expert blood glucose meter, developed by Roche. This meter is the first of its kind with a built-in insulin calculator to help guide patient therapy. You can follow this link to read a media summary of this approval, or use this link to review the FDA decision summary on this device.
FDA Approves Dulaglutide to Treat Type 2 Diabetes
September 18, 2014. The US Food and Drug Administration (FDA) has approved dulaglutide (trade name: Trulicity™), a new glucagon-like peptide-1 receptor agonist. Dulaglutide is administered as a once-weekly subcutaneous injection to improve glycemic control, alongside diet and exercise, in adults with type 2 diabetes. The FDA will require several post-marketing studies of dulaglutide, including a case registry to track medullary thyroid carcinoma incidence, an evaluation of the drug in pediatric patients, a cardiovascular (CV) outcomes trial in patients with high baseline CV risk, and a study comparing dulaglutide vs insulin glargine in patients with moderate or severe renal impairment. Dulaglutide also has a boxed warning regarding thyroid gland tumors observed in rodent studies. Follow this link to read the full FDA press release.
Glucagon-like Peptide-1 Receptor Agonist and Basal Insulin Combination Treatment for Management of Type 2 Diabetes
September 12, 2014. This systematic review and meta-analysis evaluated the effect of combined treatment with a glucagon-like peptide-1 (GLP-1) receptor agonist and basal insulin on glucose control, hypoglycemia, and weight gain in patients with type 2 diabetes (T2D). Fifteen eligible studies were identified and included in the analysis (N=4348 patients). GLP-1/basal insulin combination treatment led to improved A1C levels compared with other medication regimens evaluated (including full basal-bolus insulin replacement), did not increase hypoglycemia risk, and led to substantial mean weight reductions. The authors concluded that this treatment option could improve the management of patients with T2D. You can follow this link to read the full study abstract.
FDA Advisory Committee Recommends Approval of Liraglutide for Chronic Weight Management
September 12, 2014. The US Food and Drug Administration’s (FDA’s) Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 in favor of approving the glucagon-like peptide-1 agonist liraglutide (3 mg dose) as a treatment for chronic weight management. Liraglutide is already approved for the treatment of type 2 diabetes. Follow this link to review the FDA’s meeting announcement; this link to Healio Endocrine Today provides a summary of the FDA Advisory Committee meeting.
FDA Approves Contrave for Weight Management
September 10, 2014. The US Food and Drug Administration (FDA) has approved naltrexone hydrochloride/bupropion hydrochloride extended-release tablets (Contrave) as a treatment for chronic weight management in adults with a body mass index ≥30 kg/m2 or ≥27 kg/m2 with at least one weight-related condition such as diabetes or hypertension. Follow this link to read the full FDA announcement.
Empagliflozin to Treat Type 2 Diabetes Now Available in the U.S.
August 26, 2014. The sodium glucose co-transporter-2 empagliflozin, available as once-daily treatment with 10- or 25-mg tablets, is now available in the United States. Follow this link to read a statement from Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company.
Multicenter Closed-Loop Insulin Delivery Study Points to Challenges for Keeping Blood Glucose in a Safe Range in Adults and Adolescents with Type 1 Diabetes
July 8, 2014. The Control to Range Study was a multinational evaluation of a closed-loop artificial pancreas to assess the time spent by adults and adolescents with type 1 diabetes (N=53) in hypoglycemic and hyperglycemic states (target glucose ranges: 70 to 180 mg/dL). Mean glucose levels for adults were 159 mg/dL, with 66% of values in the target range (59% daytime, 82% overnight). Adolescents’ mean glucose levels were 166 mg/dL, with 62% of values in range (53% daytime, 82% overnight). Investigators concluded that the system performed as expected, and that both groups evaluated met prespecified safety criteria. However, the system’s performance was better overnight than during the daytime, and it was difficult to prevent some postmeal excursions from exceeding target range. Please click here to read the full article (link will work until September 25, 2014).
Adding Rapid-Acting Insulin or GLP-1 Receptor Agonist to Basal Insulin: Outcomes in a Community Setting
August 22, 2014. This retrospective matched database analysis, reported in Endocrine Practice, evaluated add-on therapy with a glucagon-like peptide-1 (GLP-1) receptor agonist vs rapid-acting insulin in patients with type 2 diabetes (T2D) already on basal insulin. Compared with rapid-acting insulin, the use of a GLP-1 receptor agonist was associated with fewer hospitalizations and lower total all-cause costs. Hypoglycemic event rates were similar in both groups. The investigators concluded that adding a GLP-1 receptor agonist provided an alternative to rapid-acting insulin treatment in patients with T2D not achieving glycemic control with basal insulin alone. Follow this link to read the study abstract or download the full article.
Type 1 Diabetes Diagnostic Antibody Test Approved by FDA
August 20, 2014. The US Food and Drug Administration (FDA) has approved the first autoantibody test to distinguish type 1 diabetes (T1D) from other diabetes types. The Zinc Transporter 8 Autoantibody (ZnT8Ab) assay detects the presence of the ZnT8 antibody (an antibody only produced in patients with T1D). When used alongside other clinical tests and information, ZnT8 assay results can improve time to diagnosis and help patients with T1D receive earlier treatment. Follow this link to read the full FDA announcement.
Glucagon-Like Peptide 1 Receptor Agonist or Bolus Insulin With Optimized Basal Insulin in Type 2 Diabetes
July 2014.This 30-week, open-label, randomized, multicenter, noninferiority trial compared the efficacy and safety of the glucagon-like peptide-1 receptor agonist exenatide vs insulin lispro in patients with type 2 diabetes (N=627) with inadequately controlled A1C levels on basal insulin plus metformin. Both treatments resulted in similar glycemic control. Patients receiving exenatide experienced weight loss, compared to weight gain with lispro. Exenatide recipients also had fewer nonnocturnal hypoglycemic events but more gastrointestinal events. The investigators concluded that these findings support the use of exenatide as a noninsulin add-on therapy for patients failing basal insulin. Click here to read the study abstract.
Type 1 Diabetes Mellitus and Cardiovascular Disease: A Scientific Statement From the American Heart Association and American Diabetes Association
August 11, 2014. The majority of published data on cardiovascular disease (CVD) in diabetes is focused on the treatment of type 2 diabetes (T2D). Additionally, most literature regarding CVD and type 1 diabetes (T1D) was conducted when glycemic control standards were less stringent than today. This review from the American Heart Association and American Diabetes Association focuses on the importance of CVD in patients with T1D. It summarizes recent evidence suggesting potential differences in the pathophysiology of atherosclerosis in T1D and T2D, as well as the implications of these findings for treatment decision-making. The statement also identifies knowledge gaps and summarizes areas for future research. Follow this link to download the full article.
Effects of Intensive Glycemic Control on Ischemic Heart Disease: Analysis of Data From the ACCORD Trial
August 1, 2014. This analysis of the randomized controlled ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial evaluated 10,251 adults with established type 2 diabetes (T2D) and risk factors for ischemic heart disease, assigned to standard or intensive glycemic control for a mean of 3.7 years. The investigators found that risk for several ischemic events including myocardial infarction, coronary revascularization, and unstable angina was significantly lower (risk reduction range, 11% to 20%) in intensively treated patients. The authors concluded that elevated glucose levels are a modifiable risk factor for ischemic heart disease in this high-risk population of patients with T2D. Read this link for a summary of the article.
Recovery of Hypoglycemia Awareness in Long-standing Type 1 Diabetes: The HypoCOMPaSS Trial
August 2014.This 24-week, multicenter, 2x2 factorial, randomized, controlled trial compared insulin pump therapy with multiple daily insulin injections and continuous vs conventional glucose self-monitoring to determine if hypoglycemic unawareness could be improved and severe hypoglycemia prevented in patients with type 1 diabetes of long-standing duration. All patients (N=96) received similar education and support, as well as therapeutic targets designed to avoid hypoglycemia while maintaining glucose control. The investigators found that, regardless of the regimen used, all patients experienced improved hypoglycemia unawareness, reduced hypoglycemic events, and maintained their glucose targets. You can read the full study abstract here.
Liraglutide Reverses Pronounced Insulin-Associated Weight Gain, Improves Glycemic Control, and Decreases Insulin Dose in Patients With Type 2 Diabetes
June 2014. This 26-week randomized controlled trial was designed to evaluate whether the addition of the glucagon-like peptide-1 (GLP-1) analogue liraglutide to insulin therapy could reverse insulin-mediated weight gain and maintain glycemic control in patients with type 2 diabetes. Fifty patients were randomized to receive add-on open-label liraglutide (n=26) or to continue standard insulin therapy (n=24). Investigators found that body weight decreased by 4.5 kg with liraglutide and increased by 0.9 kg with standard therapy (P<0.001). Patients receiving liraglutide also experienced additive A1C reductions and reduced insulin requirements compared to those on standard therapy (-0.77% vs +0.01% and -29 U/day vs +5 U/day; P<0.001 for both). Liraglutide was tolerated well by patients, with no severe adverse events or severe hypoglycemia. Link here to read the study abstract.
FDA Approves Jardiance (Empagliflozin) to Treat Type 2 Diabetes
August 1, 2014. The US Food and Drug Administration (FDA) has approved the sodium glucose co-transporter 2 oral medication known as Jardiance (empagliflozin) for the treatment of type 2 diabetes in adults. The drug’s safety and effectiveness were evaluated by 7 clinical trials encompassing 4480 patients. The most common side effects with empagliflozin are urinary tract infections and female genital infections. The FDA is requiring 4 postmarketing studies for this drug: completion of an ongoing cardiovascular trial; pediatric study of efficacy and safety; pediatric study of pharmacokinetics/pharmacodynamics; and an animal toxicity study focused on juvenile renal and bone development. Click here to read the full FDA press release.
Factors Associated With Weight Gain in People With Type 2 Diabetes Starting on Insulin
August 2014. This study evaluated 2179 individuals with type 2 diabetes who initiated insulin therapy in 314 centers across 12 countries. At 1 year, analyses were conducted to identify factors predictive of weight gain. Mean overall patient weight gain was 1.78 kg, and 24% of patients gained 5 kg or more. The factors found to be independently associated with weight gain were high baseline A1C, high insulin dose requirements, and lower baseline BMI. Patients’ insulin regimen was not a predictive factor. To read the full study abstract, Click here.
Treatment of Type 2 Diabetes in the Older Adult: A Review
July 2014. This review, published in the July edition of Endocrine Practice, summarizes available evidence regarding the unique challenges associated with treating diabetes in older patients and provides guidance to select treatment strategies and targets. Older patients with type 2 diabetes are a highly heterogeneous population, and multiple factors (eg, patient comorbidities, diabetes duration, and functional status) need to be taken into consideration as part of treatment decision-making. Hypoglycemia is more common in older patients, and a lack of consensus exists regarding optimal glycemic targets. Based on this, the authors emphasize the importance of individualized pharmacologic therapy and call for more clinical pharmacotherapy trials in this population. Click here to read the study abstract or download the full article.
Statins and the Risk of Diabetes: Evidence From a Large Population-Based Cohort Study
June 26, 2014. This large cohort study (N=115,709) investigated the relationship between statin therapy adherence and diabetes risk, with adherence measured as proportion of days covered (PDC). Participants were residents of the Italian Lombardy region who initiated statin treatment in 2003-2004. Participants were followed until 2010. During this time, those who initiated anti-diabetic therapy or who were hospitalized with a primary diagnosis of type 2 diabetes (T2D) were considered to have met the primary outcome (n=11,154). The investigators found that greater adherence to statin therapy was associated with an elevated risk of T2D development. Specifically, compared with patients with very-low adherence to statin therapy (PDC <25%), those with low (26%-50%), intermediate (51%-75%), and high (≥75%) adherence had the following hazard ratios (95% confidence intervals) for diabetes diagnosis: 1.12 (1.06-1.18), 1.22 (CI: 1.14-1.27), and 1.32 (CI: 1.26-1.39), respectively. Follow this link to read the study abstract.
Effect of Intensive Diabetes Treatment on Albuminuria in Type 1 Diabetes
July 18, 2014.This long-term follow-up of the Diabetes Control and Complications Trial and Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study in individuals with type 1 diabetes found that a history of intensive diabetes treatment yielded durable renal benefits that persisted over 18 years of follow-up. Specifically, patients provided with intensive treatment during the DCCT experienced a 45% risk reduction for microalbuminuria, as well as a 44% risk reduction for sustained estimated glomerular filtration rate <60 mL/min per 1.73m2. The investigators noted that such benefits should result in fewer patients requiring renal replacement therapy. Follow this link to read the full study abstract.
US Food and Drug Administration to Hold a Public Hearing Related to Confidentiality of Interim Results in Cardiovascular Outcome Safety Trials
July 15, 2014. The US Food and Drug Administration (FDA) has announced a public hearing on August 11 to discuss the confidentiality of interim results for certain cardiovascular outcomes trials (CVOTs). The purpose of the hearing is to initiate constructive discussion regarding the appropriate handling of interim analysis of CVOT results. Those wanting to present at the hearing must submit comments by July 28. The FDA will also accept electronic or written comments on the public docket after the hearing until October 10. To read the full Federal Register announcement regarding this hearing, link here.
Glucagon-Like Peptide-1 Receptor Agonist or Bolus Insulin With Optimized Basal Insulin in Diabetes
July 10, 2014. Although it is common to add mealtime insulin when basal supplementation becomes inadequate, this treatment approach can be associated with weight gain and hypoglycemia. This 30-week, open-label, multicenter, randomized noninferiority trial evaluated 627 patients with diabetes with insufficient A1C optimization following 12 weeks of insulin treatment; all patients were already receiving insulin glargine and metformin. Patients were randomized to exenatide (10-20 μg/day) or mealtime insulin lispro administered 3 times daily and titrated to a fasting plasma glucose level of 101 to 108 mg/dL. The investigators found that the exenatide regimen led to similar glycemic control levels as insulin lispro (-1.13% and -1.10%, respectively) and was well tolerated by patients. Follow this link to read the full study abstract.
Whey Protein Before Meals Reduced Blood Sugar Spikes in Type 2 Diabetes
July 2014. Because protein intake is known to stimulate glucagon-like peptide-1 (GLP-1) secretion, this study was conducted to determine whether preloading with a whey protein supplement might have beneficial glucose-lowering effects in type 2 diabetes (T2D). This randomized trial of 15 patients not currently receiving any medications except for sulfonylurea and metformin was conducted in a hospital setting. Patients who consumed 50 g of whey protein (dissolved in water) before a high-glycemic-index breakfast experienced increased early prandial and late insulin secretion, augmented GLP-1 response, and reduced postprandial glycemia. The investigators speculated that whey protein might enhance existing glucose-lowering strategies in T2D. You can follow this link to the home page of Diabetologia to download the full article.
A Randomized, Controlled Open-Label Study of Insulin Pump Therapy in Patients With Type 2 Diabetes
July 3, 2014. Prior research comparing the efficacy of insulin pump use vs multiple daily injections (MDI) in insulin-treated patients with type 2 diabetes (T2D) have yielded inconclusive results. This randomized, controlled trial (OpT2mise) of patients with T2D and poor glycemic control was conducted in 36 centers in North America, Europe, South Africa, and Israel. Mean A1C level at baseline was 9% and decreased by 1.1% at 6 months for pump-treated patients compared with 0.4% for MDI patients (between-group difference -0.7%, P<0.0001). Additionally, mean total daily insulin dose at study end was 97 units for pump users vs 122 units for MDI (P<0.0001). Click here to read the full study abstract.
Effect of Insulin Analogues on Risk of Severe Hypoglycemia in Patients With Type 1 Diabetes Prone to Recurrent Severe Hypoglycemia
May 2014. This randomized, open-label, blinded endpoint crossover trial was conducted at 7 medical centers in Denmark to determine whether treatment with insulin analogues (detemir and aspart) in patients with type 1 diabetes with recurrent severe hypoglycemia led to a reduction in rates of severe hypoglycemia vs human insulin. Investigators found that treatment with insulin analogues was associated with an absolute risk reduction of 0.51 hypoglycemic episodes per patient-year (95% confidence interval, 0.19 to 0.84). To read the study abstract, follow this link.
FDA Approves Intravitreal Steroid Implant for Diabetic Eye Disease
June 30, 2014. The US Food and Drug Administration has approved a 0.7 mg dexamethasone intravitreal steroid implant for patients with diabetic macular edema who have a lens implant or are scheduled for cataract surgery. The biodegradable implant (Ozurdex) is already approved for the treatment of macular edema after branch retinal vein or central retinal vein occlusion or the treatment of noninfectious uveitis. Link here to read a media summary regarding this recently approved treatment option.
FDA Approves Inhaled Insulin Afrezza
June 27, 2014. The US Food and Drug Administration (FDA) has approved Afrezza Inhalation Powder, a rapid-acting inhaled insulin administered at the start of each meal to improve glycemic control in adults with diabetes. Afrezza’s study program evaluated the product in 3017 patients with type 1 and type 2 diabetes. Afrezza will be marketed with a boxed warning regarding the risk of acute bronchospasm in patients with compromised respiratory function. In clinical trials, the most comment adverse events associated with Afrezza were hypoglycemia, cough, and throat pain or irritation. A Risk Evaluation and Mitigation Strategy program requiring several post-marketing studies was approved by the FDA. Click here to read full the FDA press release regarding this approval.
Liraglutide, Lifestyle Changes Reversed Prediabetes, Delayed Type 2 Diabetes Onset
June 22, 2014. Results from the SCALE (Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities) study were presented at the 16th International Congress of Endocrinology and the Endocrine Society. This randomized controlled study (N=3731) evaluated liraglutide 3.0 mg, in conjunction with lifestyle changes, in patients with overweight/obesity plus ≥1 additional risk factor (such as prediabetes, high blood pressure, or cholesterol). By the end of the initial 56-week study period, patients receiving liraglutide lost an average of 8% of their body weight (18.7 pounds) compared with 2.6% (6.2 pounds) in patients receiving placebo. Additionally, ~70% of patients with prediabetes receiving liraglutide transitioned to normoglycemia, compared with 32% of those receiving placebo (P <0.0001). A 2-year extension study is now planned. Click here to read a media summary (from Healio) of the presentation.
American Diabetes Association Sets New A1C Target for Children With Type 1 Diabetes
June 16, 2014. In a new position statement released at the American Diabetes Association’s (ADA) 74th Scientific Sessions, the ADA announced that it is decreasing recommended target blood glucose levels for youth with type 1 diabetes (T1D). The ADA now recommends that youth under 19 years of age with T1D maintain an A1C level <7.5%; previous targets were as high as 8.5%, dependent on age. This new target was set because of concerns over complications caused by prolonged hypoglycemia (ie, cardiovascular and kidney disease). New evidence indicates that prolonged hypoglycemia risk is elevated in children who maintain higher A1C levels over time. Link here to download the full statement or follow this link to read a summary from the ADA.
Long-term Follow-up of Diabetes Prevention Program Shows Continued Reduction in Diabetes Development
June 16, 2014. Fifteen-year findings from the Diabetes Prevention Program (DPP) were reported at the American Diabetes Association’s (ADA) 74th Annual Scientific Sessions. Investigators noted that interventions used to delay the development of type 2 diabetes (T2D) continued to be effective over time. Specifically, patients originally assigned to 3 years of lifestyle intervention or metformin treatment continued to have reduced rates of progression to T2D (27% and 17%, respectively) compared with patients originally assigned to placebo. It is important to note that, after the trial’s active phase, all DPP participants were provided with access to lifestyle intervention, leading to a reduction in differences among the treatment groups. The DPP investigators also reported on outcomes for microvascular complications and cardiovascular disease risk factors. Follow this link to read a detailed summary of this presentation prepared by the ADA.
Outpatient Glycemic Control With a Bionic Pancreas in Type 1 Diabetes
June 15, 2014. A 5-day outpatient trial has demonstrated that a wearable, bihormonal "bionic pancreas" improves glycemic control and decreases hypoglycemia in patients with type 1 diabetes (T1D). In this study, 20 adults and 32 adolescents with T1D took part in 2 random-order, crossover studies, using an insulin pump as control therapy. Automated glycemic management (ie, insulin and glucagon delivery) was controlled for the bionic pancreas by a continuous glucose monitor using an adaptive algorithm. Both adults and young patients experienced statistically significant declines in glucose levels, as well as less frequent hypoglycemia (for adults) and reduced frequency of hypoglycemia-related interventions (adolescents). These results were reported simultaneously at the American Diabetes Association 74th Annual Scientific Sessions and published in the New England Journal of Medicine. Click here to read the full article at NEJM.
Incidence of Pancreatitis and Pancreatic Cancer in a Randomized Controlled Multicenter Trial (SAVOR-TIMI 53) of the Dipeptidyl Peptidase-4 (DPP-4) Inhibitor Saxagliptin
June 9, 2014. This study evaluated the incidence of pancreatitis and pancreatic cancer in the SAVOR-TIMI 53 trial (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus-THrombolysis in Myocardial Infarction) over 2.1 years of follow-up. In this study, patients (N=16,492) with type 2 diabetes (T2D) and established cardiovascular (CV) disease or CV risk factors were randomized to treatment with saxagliptin or placebo. In both groups, similar, low rates of pancreatitis (26 events in the saxagliptin arm and 25 events in the placebo arm), and low rates of pancreatic cancer (5 and 12 cases in the saxagliptin and placebo arms, respectively) were found. Study investigators concluded that saxagliptin has no signal for increased pancreatitis or pancreatic cancer risk. You may follow this link to read the study abstract.
Comparison of Insulin Degludec/Insulin Aspart and Biphasic Insulin Aspart 30 in Uncontrolled, Insulin-Treated Type 2 Diabetes: A Phase 3a, Randomized, Treat-to-Target Trial
May 8, 2014. This 26-week randomized open-label trial compared insulin degludec/insulin aspart (IDegAsp) with biphasic insulin aspart 30 (BIAsp 30) in 446 adults with inadequately controlled type 2 diabetes (T2D). At study end, patients who received IDegAsp and BIAsp 30 had similar A1C levels; however, IDegAsp patients had significantly lower fasting plasma glucose and mean daily insulin dose, as well as fewer confirmed episodes of hypoglycemia than those who took BIAsp 30. To read the study abstract, link here.
Outcomes of Combined Cardiovascular Risk Factor Management Strategies in Type 2 Diabetes
March 4, 2014. This analysis of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) assessed standard vs intensive control of glucose, blood pressure (BP), and lipids on cardiovascular (CV) outcomes in 10,521 patients with type 2 diabetes (T2D). Compared with standard treatment, the risk for nonfatal myocardial infarction, nonfatal stroke, or death due to CV disease was lower in groups intensively treated for glucose (HR, 0.67; 95% CI, 0.50–0.91), blood pressure (HR, 0.74; 95% CI, 0.55–1.00), or both (HR, 0.71; 95% CI, 0.52–0.96). Researchers did not find any benefit with an intensive lipid control regimen. These results suggest that intensive blood pressure or glycemic control decreases the risk of major CV outcomes in patients with T2D. Click here to read the study abstract.
Da Qing Diabetes Prevention Study, 23-Year Follow-up: Cardiovascular and All-Cause Mortality and Diabetes Incidence After Lifestyle Intervention
June 2014. This follow-up analysis assessed the long-term impact of lifestyle intervention on mortality outcomes (cardiovascular [CV] and all-cause) and diabetes incidence in the Da Qing Diabetes Prevention Study. Patients (N=577) with impaired glucose tolerance enrolled in 1986 and were followed for 6 years; in 2009, investigators followed up with patients to assess their outcomes. Cumulative CV mortality was 11.9% in the intervention group vs 19.6% in the control group (P=0.033); all-cause mortality was 28.1% vs 38.4% (P=0.049); and diabetes incidence was 72.6% vs 89.9%, respectively (P=0.001). The investigators noted that these findings provide additional support regarding the critical role of lifestyle intervention in patients with impaired glucose tolerance. Click here to read the study abstract.
AACE/ACE Announce Gathering of Key Diabetes Stakeholders to Address Safety, Accuracy of Glucose Monitoring Devices and Related Tools
May 27, 2014. The American Association of Clinical Endocrinologists/American College of Endocrinology (AACE/ACE) will convene a national consensus conference on September 29 in Washington, DC, to address issues tied to quality, safety, and access to blood glucose monitoring devices and related supplies. This initiative will be structured to gather input from all major diabetes stakeholders and will examine factors such as: regulatory challenges; post-approval US Food and Drug Administration monitoring of the safety and accuracy of glucose strips, glucose sensors, and devices; and patient access and economic/reimbursement issues. To learn more, follow this link to the AACE press release.
3-Year Data: Exenatide Once-Weekly vs Insulin Glargine for Type 2 Diabetes (DURATION-3)
April 4, 2014. This randomized, open-label, multisite, 3-year extension of the DURATION-3 trial compared exenatide once weekly (2 mg subcutaneous injection) to daily insulin glargine in 456 insulin-naïve patients with type 2 diabetes (T2D). Patients receiving exenatide experienced significant A1C reductions compared with those on insulin glargine (-1.01% vs -0.81%, P=0.03). Serious adverse event rates overall were the same between the 2 groups, although exenatide patients were more likely to report transient gastrointestinal adverse events. Additionally, the overall hypoglycemia rate was approximately 3 times higher with insulin glargine. Investigators concluded that exenatide treatment is a viable option in T2D patients who have not yet transitioned to insulin therapy. Follow this link to read the study abstract.
Insulin Analogs—Are They Worth It? Is There a Compelling Case to Use Them?
June 2014. The June issue of Diabetes Care contains a point/counterpoint discussion on the topic of insulin analogs and their utility in treatment. Dr. George Grunberger takes a position in favor of analog use, while Dr. Mayer B. Davidson argues against analog use. Follow this link to read a summary abstract by Diabetes Care editor in chief Dr. William T. Cefalu (Note: Asubscription is required to read the full articles).
Hypoglycemia Increases Arrhythmia Risk in Type 2 Diabetes
May 2014. Recent clinical trials of intensive glycemic control in type 2 diabetes (T2D) have suggested a link between hypoglycemia and excess cardiovascular (CV) mortality. To investigate this, researchers evaluated the impact of simultaneous continuous interstitial glucose and ambulatory electrocardiogram monitoring in 25 insulin-treated patients with T2D and a history of CV disease or ≥2 CV risk factors. Measurements including arrhythmia frequency, heart rate variability, and markers of cardiac repolarization were compared between hypoglycemia and euglycemia and between hyperglycemia and euglycemia matched for time of day. They found that hypoglycemia mediated by vagal activation following the counterregulatory phase might increase arrhythmia risk in these patients. This could contribute to increased CV mortality during intensive glycemic therapy. Click here to read the study abstract.
New Studies Show Liraglutide Works in Obesity and Type 1 Diabetes
May 18, 2014. Data presented at the American Association of Clinical Endocrinologists’ (AACE) 23rd Annual Scientific and Clinical Congress indicate that liraglutide works as both an add-on to insulin in type 1 diabetes (T1D), as well as a weight loss agent in people without diabetes. In a randomized controlled trial, liraglutide (1.2 mg and 1.8 mg) significantly improved both A1C and fasting glucose in patients with T1D vs placebo. Data were also presented for liraglutide 3.0 mg in patients who were overweight (plus ≥1 comorbidity) or obese. In this study, patients had significantly greater mean body weight loss with liraglutide vs placebo (-8.0% vs -2.6%, P<0.0001). To read these abstracts, follow this link; abstract #295 is the liraglutide/T1D study, and abstract #700 is the liraglutide weight loss study. You can also follow this link to read a media summary of these presentations.
AACE Launches Blood Sugar Basics: Get to Your Goals Program, Urging Patients With Type 2 Diabetes to Work With Their Doctors to Get to Their Glucose Goals
May 14, 2014. The American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE), in association with Merck, have launched an online, step-by-step program intended to help patients with diabetes set and achieve personal A1C goals. Nearly half of US patients with type 2 diabetes (T2D) have not met their target A1C levels. Blood Sugar Basics encourages people with T2D to take a more active role in managing their disease by talking with their doctor about establishing and reaching a personal A1C goal. The program aims to enhance physician-patient dialogue around proper blood glucose management and to ensure mutual awareness of how a treatment plan is working and what next steps are required. Link here to visit the Blood Sugar Basics program website. Additionally, you can read this article to learn more about the Blood Sugar Basics program and/or follow this link to see a video of AACE’s Dr. Etie Moghissi explaining the program’s goals and why physicians will want to recommend this site as an educational resource for their patients.
AACE Releases Consensus Statement for Management of Patients Using Insulin Pump Therapy
May 17, 2014. The American Association of Clinical Endocrinologists (AACE) has issued a consensus statement outlining recommended clinical approaches to insulin pump therapy for patients with type 1 and insulin-requiring type 2 diabetes. The statement outlines the benefits of insulin pump therapy vs multiple daily insulin injections in appropriate patients, including favorable differences in glycemic control based on A1C, improved quality of life, and reductions in severe hypoglycemic episodes. The statement also emphasizes the need for medical providers to offer a uniform and comprehensive patient training program, because optimal patient success is contingent upon proper education in the therapy’s use, ongoing education and skills testing, and frequent follow-up. To read the AACE press release regarding the Insulin Pump Consensus Statement, link here; to download the full document, click here.
AACE Announces an Advanced Framework for a New Medically Actionable Diagnosis of Obesity
May 16, 2014. At its 23rd Annual Scientific and Clinical Congress, the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE) announced the release of an advanced framework for a new diagnostic and management approach to obesity. This framework emerged from the AACE/ACE Consensus Conference on Obesity, convened in March 2014, and argues that the current diagnostic definition of obesity (primarily reliant on an anthropomorphic measure of body mass index [BMI]) needs to be updated. This new definition does not depend upon BMI alone, but also the impact of weight gain on health. A 4-step approach is recommended for all patients: 1) screening using BMI with adjustments for ethnic differences; 2) clinical evaluation for the presence of obesity-related complications using a checklist; 3) staging for the severity of complications using complication-specific criteria; and 4) selection of prevention and/or intervention strategies targeting specific complications, as guided by the AACE/ACE obesity management algorithm. Follow this link to view the AACE press release related to the framework document. In addition, this link will lead you to a full draft of the comprehensive framework document.
Comprehensive Study Reveals Valuable Data About Diabetes in US Hispanic/Latino Populations
May 15, 2014. Data presented at the American Association of Clinical Endocrinologists’ (AACE) 23rd Annual Scientific and Clinical Congress outlined results from a comprehensive, multiyear medical research study examining health issues among US Hispanic/Latino groups. Findings indicate that less than half of these patients with diagnosed diabetes had the condition under control, and approximately one-third of patients with diabetes did not know they had this disease. The study also revealed significant differences in diabetes prevalence across Hispanic groups: the disease was most common among individuals of Mexican, Puerto Rican, and Dominican origin and least prevalent among those from South America. The Hispanic Community Health Study/Study of Latinos, spearheaded by the National Heart, Lung, and Blood Institute, recruited and examined more than 16,000 participants in 4 cities from 2008 to 2011 to identify risk factors that play a role in the development of cardiovascular and other diseases in Hispanics/Latinos. The study is ongoing. Link here to read an AACE press release summarizing the trial’s findings.
Efficacy and Safety of Insulin Lispro in Obese Patients With Type 2 Diabetes: Retrospective Meta-analysis of 7 Randomized Controlled Trials
May 2014. This retrospective analysis of 7 randomized controlled trials was designed to assess the efficacy and safety of insulin lispro administered to obese (≥30 kg/m2) vs non-obese patients (<30 kg/m2) with type 2 diabetes mellitus (T2DM). Both obese and non-obese patients experienced similar A1C reductions (~1.0%); however, the incidence and rate of hypoglycemia were significantly lower in obese vs non-obese patients (incidence: 53% vs 63%; rate: 0.93 vs 1.76 events per 30 days). Follow this link to the study abstract in Endocrine Practice.
American Association of Clinical Endocrinologists/American College of Endocrinology (AACE/ACE) Releases a New Consensus Statement From the Insulin Pump Management Task Force
May 9, 2014. With the proliferation of insulin pumps in medical practice, prospective and current prescribers need guidance to ensure optimal and safe use of these devices. This document summarizes the current continuous subcutaneous insulin infusion (CSII) options available to patients who are using basal bolus insulin management to control their diabetes mellitus. This document provides an update to the 2010 AACE/ACE Consensus Statement on Insulin Pump Management. Follow this link to download the full Consensus Statement and its associated slide kit.
Beta-Cell Failure in Type 2 Diabetes: Postulated Mechanisms and Prospects for Prevention and Treatment
May 8, 2014. This summary report examines the foundation of beta-cell failure in type 2 diabetes and was based on a conference sponsored by the American Diabetes Association and the Endocrine Society. Topics covered include foundations and natural history of beta-cell failure, the role of genetics, the impact of therapeutic interventions, and suggestions for further research. Click here to read the report abstract and download the full article.
Nocturnal Hypoglycemia May Increase Arrhythmia Risk in Type 2 Diabetes
May 2014. In this study, 25 insulin-treated patients with type 2 diabetes and at high cardiovascular risk received simultaneous interstitial glucose and ambulatory electrocardiogram monitoring. The frequency of arrhythmias, heart rate variability, and cardiac repolarization markers were compared against the timing of hyperglycemia, hypoglycemia, and euglycemia. The investigators found that arrhythmias were more common during nighttime vs daytime hypoglycemia and proposed that excessive compensatory vagal activation following the counterregulatory phase might account for these findings. This could contribute to increased cardiovascular mortality during intensive glycemic therapy. Link here to read the study abstract.
Metformin Safety in Gestational Diabetes
May 1, 2014. This retrospective study, published in Endocrine Practice, evaluated the neonatal and maternal safety of metformin used in gestational diabetes mellitus (GDM). The records of 186 patients with GDM were compared; 32 (17.2%) were treated with metformin, while the rest were treated with diet only (n=121) or insulin (n=33). Investigators found no statistically significant differences between metformin-, insulin-, and diet-treated patients for multiple complications, leading the authors to suggest that metformin is a safe option for use in GDM. To read the study abstract, click here.
FDA Safety Communication: GenStrip Blood Glucose Test Strips by Shasta May Report False Results
April 29, 2014. The US Food and Drug Administration (FDA) has advised patients and health care providers to stop using GenStrip Blood Glucose Test Strips because the strips may report incorrect blood glucose levels. During a recent inspection, the FDA found that the manufacturer, Shasta Technologies, did not have many of the requirements of a quality system in place. Without this assurance, the FDA believes that GenStrip strips could report incorrect blood glucose levels. Follow this link to read the full FDA press release.
Accurate Insulin Decisions Initiative Puts Insulin Management in an App
April 26, 2014. The Accurate Insulin Decisions (AID) program has been launched to give patients with diabetes new tools to help manage their insulin use and improve glycemic control. First, the AID program leads patients through a questionnaire regarding their insulin use, goals, and priorities. Following this, patients can use AID online or as a phone app to track their insulin dosing and make adjustments as needed. AID was developed by The Endocrine Society, American Diabetes Association, American Association of Diabetes Educators, and other major organizations. Click here to visit the AID website.
Combination Therapy With MET + SU vs MET + DPP-4 Inhibitor: Association With Major Cardiovascular Events and All-Cause Mortality
April 25, 2014. This retrospective, propensity-matched cohort analysis used data from the United Kingdom Clinical Practice Research Datalink to evaluate the risk of major adverse cardiovascular events (MACE) and all-cause mortality in patients with type 2 diabetes receiving metformin combined with either a sulfonylurea or a dipeptidyl peptidase-4 (DPP-4) inhibitor. Investigators found reduced all-cause mortality in patients treated with the DPP-4 inhibitor vs sulfonylurea (adjusted hazard ratio [aHA] for the propensity-matched cohort: 1.497, 95% confidence interval [CI], 1.092-2.052). A reduction in MACE events was also observed for DPP-4 inhibitor patients (aHA for the propensity-matched cohort: 1.547, 95% CI 1.076-2.225). To read the study abstract, follow this link.
FDA to Review Empagliflozin/Linagliptin Combination
April 14, 2014. Eli Lilly and Company and Boehringer Ingelheim Pharmaceuticals have submitted a New Drug Application to the U.S. Food and Drug Administration for an empagliflozin/linagliptin combination tablet for the treatment of type 2 diabetes. If approved, this drug will be the first single pill combining dipeptidyl peptidase-4 (DPP-4) inhibitor and sodium glucose co-transporter-2 (SGLT-2) therapy. For more information, follow this link to read a media summary.
Reduced Risk of Hypoglycemia With Insulin Degludec vs Insulin Glargine in Patients With T2DM Requiring High Doses of Basal Insulin
April 2014. This post hoc meta-analysis of 5 randomized trials compared overall and nocturnal confirmed hypoglycemia rates in a pooled analysis of >3000 patients with type 2 diabetes using basal insulin glargine or degludec. Investigators found that patients achieved similar A1C reductions with both insulin types but had significantly less hypoglycemia (overall, 21%; nocturnal, 52%) with degludec compared with insulin glargine. Click here to read the study abstract and/or download the article from Endocrine Practice.
Does Availability of Reliable Home Blood Glucose Data at Clinical Appointments Improve Glycemia?
April 2014. This review of 500 charts of patients with diabetes, who were either commercially insured or treated at a Managed Medicare/Medicaid Diabetes Clinic, was conducted to determine whether the patients provided reliable self-monitored blood glucose (SMBG) data at clinical visits and to determine whether reliable SMBG was associated with improved A1C levels. Investigators found that only a minority of diabetes patients, mostly insulin-treated, provided reliable SMBG data. Additionally, only insulin-requiring Medicare/Medicaid patients with poorly controlled diabetes had a significant A1C reduction associated with reliable SMBG. Link here to read the abstract and article.
FDA Approves Albiglutide, a Glucagon-like Peptide-1 Receptor Agonist
April 15, 2014. The US Food and Drug Administration (FDA) has approved albiglutide (trade name, Tanzeum), a once-weekly glucagon-like peptide-1 receptor agonist for type 2 diabetes. According to its press release, the FDA will require certain post-marketing research, as well as a risk evaluation and mitigation strategy to inform healthcare providers about potential serious risks (thyroid tumors) associated with albiglutide. You can click here to read the full FDA press release.
Food and Drug Administration Extends Review of New Inhaled Insulin Device by 3 Months
April 7, 2014. Following a US Food and Drug Administration (FDA) advisory panel’s April 1 recommendation to approve MannKind’s inhaled insulin treatment Afrezza, the FDA has extended the review date by 3 months. The FDA has requested longer-term studies to assess the risk of lung cancer, as well as other potential side effects of the treatment. Link here for a media summary, or click here to read the MannKind press release.
Bariatric Surgery May Provide Better, More Durable Control of Type 2 Diabetes Than Medical Therapy
March 31, 2014. Data from the STAMPEDE study, presented at the American College of Cardiology meeting and simultaneously published in the New England Journal of Medicine, summarized results from a 3-year follow-up study of 150 patients with severely uncontrolled type 2 diabetes mellitus (T2DM) randomized to bariatric surgery plus intensive medical therapy or intensive medical therapy alone. Investigators found that surgery patients had better and more durable T2DM control. Improvements were also seen in outcomes such as body weight, use of glucose-lowering medications, and patient quality of life. To read the full article, follow this link.
Health Insurance Plans for Federal Employees Will Now Cover Obesity Treatment
March 20, 2014. Health insurance plans for federal employees, about 2.7 million individuals, will now cover medications for obesity, including phentermine/topiramate and lorcaserin, as well as lifestyle intervention. A letter from the US Office of Personnel Management, Healthcare and Insurance, notes that it is not permissible to “exclud[e] weight loss drugs from…coverage on the basis that obesity is a ‘lifestyle’ condition and not a medical one or that obesity treatment is ‘cosmetic.’” This move on the part of the federal government could set the stage for private insurers to follow. Click here to read the letter from a federal regulator, and link here for a media summary.
FDA Panel Will Evaluate Pulmonary Effects of Inhaled Insulin
March 30, 2014. The US Food and Drug Administration (FDA) has documented several safety and efficacy issues of potential concern related to the pulmonary effects of inhaled insulin that it will ask its Endocrinologic and Metabolic Drugs Advisory Committee to address at a meeting this week. This announcement was made in advance of the FDA hearing on MannKind’s Technosphere inhaled insulin product. Click here to read a media summary of this story, and link here to download the associated FDA briefing documents (note: this is a large document and may take some time to download).
Alogliptin Shows No Effect on Cardiovascular Mortality or Heart Failure Hospitalization
March 28, 2014. Data from the EXAMINE trial (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome), reported at the American College of Cardiology Scientific Sessions, indicate that the dipeptidyl-peptidase 4 inhibitor alogliptin is not associated with increased cardiovascular mortality or heart failure hospitalization risk in patients with type 2 diabetes. Link here to read a media summary of these results, and click here for a press release from the drug’s manufacturer.
A1C Is Not a Good Predictor of Cardiovascular Events
March 26, 2014. This analysis of individual participant data (N=294,998) from 73 prospective studies indicates that adding A1C levels to conventional cardiovascular (CV) risk assessments provides little benefit to CV risk prediction in individuals without diabetes or prior CV disease. Click here to read the study abstract.
AACE Obesity Consensus Conference Produces Basis for Concerted Action Plan
March 25, 2014. Today, the American Association of Clinical Endocrinologists/American College of Endocrinology (AACE/ACE) announced the outcome of its AACE/ACE Consensus Conference of Obesity: Building an Evidence Base for Comprehensive Action. Key findings include the need for an improved definition of obesity, high-quality research including evaluation of a complications-centric clinical approach to obesity, and better understanding of reimbursement mechanisms. Next steps include translating these findings into actionable recommendations for individual patients that are likely to succeed and developing logistics for effective implementation. Click here to read the AACE/ACE press release; you can also read media summaries here and here.
Cardiometabolic Implications of Postpartum Weight Changes in the First Year After Delivery
March 25, 2014. This prospective study evaluated the impact of postpartum weight change on women’s cardiometabolic risk factors within 1 year of childbirth. Most women (74.4%) lost weight during this time frame, but among those who did not lose weight within 3 to 12 months of delivery, investigators found a significant adverse cardiometabolic risk profile. To read the study abstract, link here.
BMI and All-Cause Mortality in Older Adults: A Meta-analysis
March 2014. This 2-stage random-effects meta-analysis of adults 65 years of age or older (N=197,940) found that, compared with a reference body mass index (BMI) range of 23.0-23.9 kg/m2, individuals with lower BMI (≤21.9 kg/m2) or who had a BMI in excess of 33 kg/m2 had elevated all-cause mortality risk. However, older individuals who were overweight or only mildly obese did not have higher all-cause mortality. Click here to link to the study abstract.
Hypoglycemic Risk in Randomized Controlled Trials With Sulfonylureas in Patients With Type 2 Diabetes
March 17, 2014. This meta-analysis evaluated randomized clinical trials of ≥24 weeks’ duration to assess hypoglycemic risk in patients receiving sulfonylureas as part of their overall diabetes regimen. Investigators found that hypoglycemia risk was 20% higher in patients receiving sulfonylureas and that severe hypoglycemia risk more than tripled in this group. Additionally, investigators found higher hypoglycemia risk in patients treated with sulfonylureas who had lower baseline A1C levels and higher body mass index. To read the study abstract, click here.
Insulin-Related Hypoglycemia a Significant Cause of Emergency Room Visits
March 10, 2014. This analysis from the U.S. Centers for Disease Control and Prevention evaluated rates of emergency department (ED) visits and subsequent hospitalizations for insulin-related hypoglycemia. Nationally representative data (2007-2011) were obtained from the National Electronic Injury Surveillance System/Cooperative Adverse Drug Event Surveillance project and the National Health Interview Survey. Investigators found that insulin-related hypoglycemia and errors leading to ED visits and subsequent hospitalization were highest in patients 80 years or older and recommended that this risk be considered as part of insulin prescribing and intensification decisions. Link here to read the full study abstract.
Up to One-third of Obese Children May Be Metabolically Healthy
February 26, 2014. According to a recent cross-sectional analysis of 8- to 17-year-olds with body mass index ≥85th percentile, up to 1 in 3 children with obesity may potentially be metabolically healthy. Study participants were classified as metabolically healthy or unhealthy based on insulin resistance and cardiometabolic risk factors and with multivariate logistic regression used to identify variables predictive of metabolically healthy obesity (these included waist circumference, dietary fat intake, and moderate-to-vigorous physical activity). The investigators noted that these findings may help providers determine which patients require health services prioritization. Click here to read the study abstract.
Midlife Type 2 Diabetes and Poor Glycemic Control Are Risk Factors for Cognitive Decline in Early Old Age
March 2014. In this post-hoc analysis of the United Kingdom Whitehall II cohort study, 5653 participants (median age 54.4 years) were categorized into 4 groups: normoglycemic, prediabetes, newly diagnosed diabetes, and existing diabetes. Cognitive tests were administered to participants 3 times over 10 years. Compared with normoglycemic participants, those with known diabetes had faster declines in memory (45%; P=0.046), reasoning (29%; P=0.026), and global cognitive score (24%; P =0.014). Participants with prediabetes or newly diagnosed diabetes had similar rates of decline as those with normoglycemia. Link here to review the study abstract.
US Food and Drug Administration Approves Bydureon Pen
March 3, 2014. The US Food and Drug Administration has approved a pen formulation for delivery of weekly exenatide (Bydureon) in adults with type 2 diabetes. The pen eliminates the need for patients to transfer the medication between a vial and a syringe during the self-injection process. Click here to read a press release with more information.
Cardiovascular Risk Profile in Patients With Prediabetes and New-Onset Type 2 Diabetes Identified by A1C Testing
February 26, 2014. This study evaluated the cardiovascular (CV) risk profile of 274 patients with prediabetes and newly diagnosed type 2 diabetes (based on A1C testing). Patients also received fasting plasma glucose (FPG) and oral glucose tolerance testing (OGTT). Investigators found that patients with prediabetes based on A1C level, but with normal FPG and OGTT results, had an altered intima-media thickness and augmentation index. These data suggest that A1C testing may be better than FPG or OGTT alone in identifying prediabetic patients at high CV risk. To read the study abstract, click here.
FDA to Roll Out New Food Labels Focused on Caloric Intake, Sugar, and Serving Size
February 27, 2014. The US Food and Drug Administration (FDA) has announced a plan to update the Nutrition Facts label for packaged foods to reflect the latest scientific information, including the link between diet and chronic diseases such as obesity and heart disease. The proposed label will also be required to include information on the amount of added sugars and will feature a new design to highlight key parts of the label such as calories and serving sizes. The FDA is accepting public comment on the proposed changes for the next 90 days. Click here to read the full FDA press release regarding the new labeling.
FDA and European Medicines Agency Release Assessment Regarding Pancreatic Risk of GLP-1 Drugs
February 27, 2014. In an editorial in the latest issue of The New England Journal of Medicine, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) summarize their recent collaborative effort reviewing nonclinical toxicology studies, clinical trial data, and epidemiologic data related to incretin therapies for the treatment of type 2 diabetes and pancreatic safety. The two agencies agree that a causal relationship is not consistent with currently available data, although no final conclusion can be reached at this time. Click here to read the full editorial.
Diabetes Prevention Bill Would Cut Medicare Costs, Improve Patient Health, Study Says
February 12, 2014. According to a study commissioned by the American Diabetes Association (ADA), American Medical Association (AMA), and the National Council of Young Men's Christian Association (YMCA), the proposed Medicare Diabetes Prevention Act could decrease the rate of diabetes among Medicare patients by more than one-third, as well as cut federal spending by $1.3 billion between 2015 and 2024. The bill would provide reimbursement for a group-based 16-session lifestyle intervention program, the National Diabetes Prevention Program (DPP), for Medicare recipients diagnosed with prediabetes. Click here to read the full ADA/AMA/YMCA statement.
The Health and Retirement Study 1998-2010: Association of Functional Decline With Subsequent Diabetes Incidence in US Adults Aged 51 Years and Older
February 18, 2014. This nationally representative observational follow-up study was designed to determine whether functional decline and physical disability increase diabetes risk. It included 22,878 adults tracked for an average of 8.7 years. Results suggested that individuals with any level of functional decline are at increased risk of developing diabetes (28% to 95% elevated risk). The researchers suggest that preventing disability in older adults might also reduce diabetes incidence. Follow this link to read the study abstract.
Impact of Improved Beta-Cell Function on Glycemic Variability in Patients With Early Type 2 Diabetes
February 18, 2014. The objective of this study was to determine whether short-term intensive insulin therapy (IIT), administered to improve beta-cell function in patients with early type 2 diabetes (T2DM), would also improve glycemic variability. Sixty-one patients with T2DM of 3 years’ mean duration received 4 weeks of IIT (consisting of basal insulin detemir, and premeal insulin aspart). Between the first and last week of IIT, 55.7% of patients experienced a reduction in glycemic variability. Click here to read the study abstract.
AACE/ACE to Hold International Obesity Consensus Conference
February 18, 2014. In March 2014, the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) will hold a 2-day conference in an effort to curtail and reduce the prevalence of obesity. During this conference, representatives from the physician community, public health, government, health care companies, medical research and educational communities, related medical societies and associations, and pharmaceutical companies will address the following 5 questions: 1) What is obesity? 2) What options are available for obesity management? 3) What is the optimal use of therapeutic modalities? 4) Can the optimal framework be cost effective? 5) What are the knowledge gaps and how can they be filled? Click here to read the AACE/ACE press release about this meeting.
More Than 180 Diabetes Treatments Are in the Pipeline
February 12, 2014. According to America’s biopharmaceutical research companies, more than 180 medicines are currently being developed to treat diabetes. These include 30 drugs for type 1 diabetes, 100 for type 2 diabetes, and 52 for diabetes-related conditions. Click here to read a media summary of this research.
FDA to Review Saxagliptin Heart Failure Risk
February 11, 2014. To investigate a possible association between treatment with saxagliptin and heart failure, the US Food and Drug Administration (FDA) has requested clinical trial data from the SAVOR-TIMI 53 study, published recently in the New England Journal of Medicine.
This study reported an increased heart failure–related hospitalization rate in patients treated with saxagliptin. The manufacturer is expected to submit its data to FDA by early March, after which the FDA will conduct a thorough analysis and report its findings publicly. Follow this link to read the full FDA press release and/or to submit an adverse event report for saxagliptin.
Treatment of Type 2 Diabetes in the Older Adult: A Review
February 11, 2014. A review article in this month’s issue of Endocrine Practice discusses the needs of older patients with type 2 diabetes. The authors note that older patients are a heterogeneous population with substantial comorbidities. Barriers to effective management include the lack of consensus regarding “optimal” glucose targets for older patients and elevated hypoglycemia risk (which can contribute to increased morbidity and reduced quality of life and can limit treatment decision making). Follow this link to download the full article.
ACCORD MIND Study: No Diabetes or Dementia Benefit From Blood Pressure Control or Fibrate Treatment
February 2014. This analysis of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Memory in Diabetes (MIND) trial evaluated high-risk type 2 diabetes mellitus (T2DM) patients (N=2977) with no evidence of dementia or cognitive impairment at baseline. Patients were randomized to intensive or conventional blood pressure (BP) control (<120 mm Hg or <140 mm Hg, respectively) or to treatment with fibrate vs placebo. Patient cognition was tested at baseline, 20, and 40 months. Neither BP control or fibrate therapy significantly impacted cognitive decline at 40 months, although a sub-study of total brain volume (TBV) found that intensive BP control was associated with a lower decline in TBV compared with standard treatment. Click here to read the study abstract.
Once-Weekly Albiglutide vs Once-Daily Liraglutide in Patients With Type 2 Diabetes Inadequately Controlled on Oral Drugs
February 6, 2014. This head-to-head, randomized, open-label, multicenter non-inferiority Phase 3 study compared 812 adults with inadequately controlled type 2 diabetes treated with the glucagon-like peptide-1 receptor agonists albiglutide (weekly administration) and liraglutide (daily administration). At 32 weeks, patients receiving liraglutide had greater A1C reductions than those taking albiglutide (0.99% vs 0.78%). Additionally, patients who received albiglutide had a higher rate of injection-site reactions and fewer gastrointestinal events than patients in the liraglutide group. You can review the study abstract here.
FDA Approves Pediatric Use of Dexcom’s G4 Platinum Continuous Glucose Monitoring System
February 3, 2014. The U.S. Food and Drug Administration (FDA) has approved the use of the Dexcom G4 Platinum Continuous Glucose Monitoring System for patients with diabetes aged 2 to 17 years. Previously, this device was approved only for patients aged 18 years or older. Click here to read the FDA press release.
Type 2 Diabetes Prevention: Which Approaches Work Best?
January 29, 2014. This systematic review and meta-analysis evaluated the effectiveness of different strategies to prevent type 2 diabetes mellitus (T2DM). Seventy-one controlled trials and 15 diabetes prevention strategies were included in the analysis. Evaluated interventions included diet and physical activity, specific antidiabetic and cardiovascular/lipid-lowering drugs, certain nutrients, estrogens, alcohol, and bariatric surgery. Investigators found that lifestyle and several drugs (with the exception of beta-cell stimulating drugs) were effective in preventing T2DM, with statistically significant odds ratios (ORs) ranging from 0.37 to 0.85. The most effective strategy was bariatric surgery (OR 0.16) in morbidly obese patients. Follow this link to read the study abstract.
Medicare’s Diabetes Testing Supply Program Is Limiting Patient Choice and Access
January 2014. A study conducted by the American Association of Diabetes Educators (AADE) suggests that Medicare's Competitive Bidding Program for mail-order diabetes testing supplies is limiting beneficiaries' access. Specifically, AADE contacted 23 eligible Medicare mail-order diabetes testing suppliers and found that only 3 suppliers carried each brand of diabetes testing supplies they reported having, while no suppliers had more than 50% of the product offerings listed on the Medicare website. AADE concluded that Medicare beneficiaries have reduced choice and access to diabetes testing supplies as a result of the Competitive Bidding Program. The full study report can be downloaded from the AADE website.
A1C Test Can Be Used Early to Detect Diabetes Risk
November 2013. This community-based historic cohort study followed 10,201 patients who were at high risk for, but not diagnosed with, type 2 diabetes mellitus (T2DM) at baseline. Patients’ A1C levels were measured at baseline and over the subsequent 5 to 8 years. Investigators found that A1C levels ≥5.5% were associated with increased T2DM risk and noted that these data support the use of A1C testing as a screening tool in high-risk populations. Follow this link to read the study abstract on PubMed.
Reversal of Early Abnormalities in Glucose Metabolism in Obese Youth: Results of an Intensive Lifestyle Randomized Controlled Trial
February 2014. This parallel-group, randomized controlled trial compared the impact of the Bright Bodies (BB) lifestyle program vs standard care on 2-hour oral glucose tolerance (OGTT) in adolescents with elevated OGTT at baseline. Investigators found that youth who participated in the BB program experienced significantly decreased OGTT levels (−27.2 mg/dL for BB vs −10.1 mg/dL for standard care; P = 0.005), as well as significant improvement on other markers of insulin resistance. Click here to read the full study abstract.
Severe Hypoglycemia and Cognitive Decline in Older People With Type 2 Diabetes: The Edinburgh Type 2 Diabetes Study
February 2014. Hypoglycemia may be a risk factor for age-related cognitive decline in patients with type 2 diabetes; however, the direction of this relationship is not clear. This study evaluated cognitive function in 831 adult patients (60 to 75 years of age) from the Edinburgh Type 2 Diabetes Study for self-reported historical and incident hypoglycemia, respectively, at baseline and 4 years. The authors noted that the “relationship between cognitive impairment and hypoglycemia appeared complex, with severe hypoglycemia associated with both poorer initial cognitive ability and accelerated cognitive decline.” To read the study abstract, click here.
Caffeinated and Decaffeinated Coffee Consumption and Type 2 Diabetes Risk
February 2014. This systematic review/dose-response meta-analysis included 28 prospective studies, with follow-up durations ranging from 10 months to 20 years. Investigators found that coffee consumption (caffeinated or decaffeinated) was inversely associated with type 2 diabetes risk in a dose-response manner. Click here to read the full study abstract.
Insulin Stacking vs Therapeutic Accumulation—What’s the Difference?
January-February 2014. This review clarifies the difference between inappropriate insulin stacking (wherein shorter-acting insulin formulations are used repeatedly to correct hyperglycemia, a practice that can lead to hypoglycemia) vs the appropriate accumulation of long-acting insulins dosed to steady-state pharmacokinetic profiles. To read the abstract or download the full article from Endocrine Practice, click here.
Real-World Treatment Persistence to Insulin in Type 2 Diabetes
January-February 2014. This study of 4804 patients with type 2 diabetes mellitus (T2DM; insulin glargine: 4,172, insulin detemir: 632) used pooled patient data from 3 published retrospective, observational studies to evaluate treatment persistence with initial insulin therapy. Over 1 year of follow-up, the average persistence rate was 65%. Significantly higher persistence was associated with older age, insulin glargine, and/or baseline exenatide or sitagliptin use. In addition, patients who had lower A1C levels at follow-up, greater A1C reductions from baseline, and/or less healthcare utilization had higher persistence rates. To read the abstract or download the full article from Endocrine Practice, click here.
US Preventive Services Task Force Issues Recommendations on Gestational Diabetes Testing
January 2014. The US Preventive Services Task Force (USPSTF) has released new, B-evidence level guidelines regarding screening for gestational diabetes mellitus (GDM). According to the USPSTF, all pregnant women should be screened for gestational diabetes at 24 weeks of pregnancy. These GDM recommendations align with those of the American Association of Clinical Endocrinologists, as well as several other major medical organizations. To review the current recommendations, click here; for a media summary of the USPSTF recommendations, follow this link.
FDA Approves Dapagliflozin for Type 2 Diabetes
January 8, 2014. The U.S. Food and Drug Administration (FDA) approved the sodium-glucose co-transporter 2 drug dapagliflozin (trade name Farxiga) for patients with type 2 diabetes. As part of this agreement, 5 post-marketing studies will be required to assess the impact of dapagliflozin on cardiovascular outcomes and bladder tumor risk and in pediatric patients. Additionally, a pharmacovigilance program will be established to monitor the drug’s effects on liver abnormalities and pregnancy outcomes. Click here to read the FDA press release.
FDA Issues Draft Guidance Documents for Over-the-Counter vs. Point-of-Care Glucose Monitoring
January 7, 2014. The U.S. Food and Drug Administration (FDA) released 2 draft guidance documents distinguishing between over-the-counter (OTC) and prescription point-of-care (POC) blood glucose monitoring. This represents a departure for the FDA, which previously did not distinguish between consumer and professional blood glucose monitor use. The OTC glucose monitor guidance can be downloaded here from the FDA web site, and the POC guidance is available here. In addition, this link from MedPageToday provides a brief summary of the draft guidance documents. Both documents are open for comments for 90 days.
American Diabetes Association 2014 Standards of Care Emphasize Individualized Treatment
December 31, 2013. The American Diabetes Association (ADA) released its annual Standards of Medical Care in Diabetes for 2014, with an emphasis on individualized diabetes treatment. Use this link to download the full guidelines. You can follow this link to download a slide kit summarizing the new guidelines. Additionally, a summary of revisions made to the 2014 guidelines is available at this link.
Extreme Cases of Obesity Are Up in United States
December 24, 2013. According to the U.S. Centers for Disease Control and Prevention (CDC), obesity rates among Americans overall have remained flat, but the percentage of people who are extremely obese (also known as Class 3 obesity, representing individuals with a body mass index of 40 kg/m2 or more) has increased. Specifically, the percentage of the extremely obese U.S. adult population rose from 2.8% in 1994 to 6.3% in 2010. The updated CDC weight charts can be viewed and downloaded here. You can follow this link to a media summary of this story, published by USA Today.