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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.