In The News

DEVOTE Study: Efficacy and Safety of Degludec Versus Glargine in Type 2 Diabetes

June 12, 2017. This randomized, double-blind, treat-to-target cardiovascular (CV) outcomes trial was undertaken to evaluate the CV safety of insulin degludec compared with insulin glargine. Patients with type 2 diabetes (N=7,637) were randomly assigned to receive insulin degludec or glargine U100 once daily between dinner and bedtime. The primary composite outcome was death from CV causes, nonfatal myocardial infarction, or nonfatal stroke, with a prespecified noninferiority margin of 1.3. The secondary outcome was severe hypoglycemia.

Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes: CANVAS Program Collaborative Group

June 12, 2017. This study reports on the cardiovascular, renal, and safety outcomes of canagliflozin treatment in patients with type 2 diabetes (T2D) and high cardiovascular (CV) risk. Data were analyzed from 2 trials (N=10,142) in which patients were assigned to receive canagliflozin or placebo and followed for a mean of 188.2 weeks. Mean participant age was 63.3 years, and 65.6% had a history of CV disease. The mean duration of diabetes was 13.5 years. The primary outcome was a composite of death from CV causes, nonfatal myocardial infarction, or nonfatal stroke.

Severe Hypoglycemia Among Patients With Type 2 Diabetes Requiring Emergency Hospital Admission: The HIPOS-ER Study

June 5, 2017. This cross-sectional, observational, multicenter study analyzed the prevalence of severe hypoglycemia in patients with type 2 diabetes taking antihyperglycemic agents and requiring emergency room (ER) assistance. Over the study period, data from 425,706 ER admissions were evaluated, and 238 (0.074%) patients met the study criteria. Median patient age was 77.5 years, and patients had a mean duration of diabetes of 19 years; 55% were on insulin therapy and 31.5% were receiving oral secretagogues.

Lower Risk of Heart Failure and Death in Patients Initiated on SGLT-2 Inhibitors Versus Other Glucose-Lowering Drugs: The CVD-REAL Study

May 18, 2017. This retrospective, matched, multinational claims analysis (N=309,056) was conducted to determine whether real-world data confirmed clinical trial findings of decreased rates of cardiovascular (CV) death and hospitalization for heart failure (HHF) in patients using sodium glucose co-transporter-2 (SGLT-2) inhibitor drugs. All patients had type 2 diabetes and atherosclerotic CV disease; propensity matching was used to compare patients using SGLT-2 inhibitors vs other glucose-lowering agents.

FDA Consumer Update: How to Safely Use Glucose Meters and Test Strips for Diabetes

May 16, 2017. The US Food and Drug Administration (FDA) has released a consumer update regarding the purchase and use of previously owned test strips for glucose meter testing. Some sellers are now marketing pre-owned or secondhand test strips, which may be sold at lower prices compared with new strips. Although this practice is technically legal, the FDA does not recommend that patients buy pre-owned test strips or resell unused strips because pre-owned strips can give incorrect results and may not be safe to use with specific devices.

Bydureon EXSCEL Trial Meets Primary Safety Objective in Type 2 Diabetes Patients at Wide Range of Cardiovascular Risk

May 23, 2017. Top-line results from the Phase IIIb/IV EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial have been announced by the drug’s manufacturer. The trial compared once-weekly injectable extended-release exenatide (Bydureon) vs placebo in adults with type 2 diabetes (T2D) and a wide range of cardiovascular (CV) risk profiles. More than 14,000 patients from 35 countries participated. The primary outcome was a composite of major adverse cardiac events (MACE): CV death, nonfatal myocardial infarction, or nonfatal stroke.

Hypoglycemia Seriousness and Weight Gain as Determinants of Cardiovascular Disease Outcomes Among Sulfonylurea Users

May 12, 2017. This cohort study quantified the association between cardiovascular disease (CVD) outcomes with hypoglycemia and weight gain in patients with type 2 diabetes treated with sulfonylureas. Patients were identified from a national electronic health database (dates: January 2009 to December 2014). Hypoglycemic events were identified and characterized as serious or nonserious.

FDA Confirms Increased Risk of Leg and Foot Amputations With Diabetes Medicine Canagliflozin

May 16, 2017. The US Food and Drug Administration (FDA), in a Drug Safety Communication, has concluded that the type 2 diabetes medicine canagliflozin (brand names Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations.

Rates of Hypoglycemia Are Lower in Patients Treated With Insulin Degludec/Liraglutide Than With Insulin Degludec or Insulin Glargine Regardless of the Hypoglycemia Definition Used

April 17, 2017. Reported hypoglycemia rates in clinical trials have been shown to vary based on the hypoglycemia definition used. This post-hoc analysis applied data from the DUAL I and DUAL V trials, which compared once-daily, fixed ratio insulin degludec/liraglutide (IDegLira) vs the basal insulin regimens degludec and glargine. These data were re-analyzed using two definitions of hypoglycemia (confirmed hypoglycemia and American Diabetes Association-documented symptomatic hypoglycemia).

FDA Approves Ranibizumab Injection for Diabetic Retinopathy in Patients With or Without Diabetic Macular Edema

April 18, 2017. The U.S. Food and Drug Administration (FDA) has approved ranibizumab injection administered monthly for all forms of diabetic retinopathy. With this approval, ranibizumab is the only FDA-approved medication to treat diabetic retinopathy in patients with or without diabetic macular edema.