In The News

FDA Announces Voluntary Recall of OmniPod (Pod) Insulin Management System by Insulet Corporation

August 28, 2015. The US Food and Drug Administration (FDA) has announced a voluntary recall of 40,846 boxes of the OmniPod (Pod) Insulin Management System, manufactured by the Insulet Corporation. This corrective action is due to the possibility that some Pods from these lots may have a higher failure rate than Insulet's current manufacturing standards. There are 2 ways in which these Pods may fail: 1) the cannula may either completely retract or fail to fully deploy; or 2) the Pod may trigger an audible alarm indicating it will no longer deliver insulin and will need to be replaced.

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.

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.

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.

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.

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.

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.

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%).

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.

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.