In The News

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. Click here for full article

Factors Associated With Improved Glycemic Control Following Continuous Subcutaneous Insulin Infusion Therapy in Patients With Type 2 Diabetes Uncontrolled With Bolus-Basal Insulin Regimens: An Analysis From the OpT2mise Randomized Trial

April 4, 2017. This analysis investigated factors associated with A1C decreases in patients receiving continuous subcutaneous insulin infusion (CSII) as part of the OpT2mise randomized trial. Patients with type 2 diabetes (T2D) and A1C levels >8% following multiple daily injection (MDI) optimization were randomized to receive CSII (n=168) or MDI (n=163) for 6 months. Investigators found that CSII produced a significantly greater reduction in A1C versus MDI; this treatment difference was more pronounced in patients with higher baseline A1C.

The LixiLan-L Trial: Consistent Findings in Glycemic Control, Body Weight, and Hypoglycemia With iGlarLixi Vs Insulin Glargine Across Baseline A1C, Body Mass Index, and Diabetes Duration

This exploratory analysis was conducted to determine the impact of patient baseline characteristics on outcomes observed in the LixiLan-L randomized open-label trial (N=736). This 30-week trial evaluated the efficacy and safety of iGlarLixi (insulin glargine 100 U [iGlar]) plus lixisenatide) vs iGlar alone in patients with type 2 diabetes (T2D). To be included in the study, patients were required to be inadequately controlled on a regimen of basal insulin alone or in combination with 1 or2 oral glucose-lowering drugs.

A Fixed Ratio Combination of Insulin Degludec and Liraglutide (IDegLira) Reduces Glycemic Fluctuation and Brings More Patients With Type 2 Diabetes Within Blood Glucose Target Ranges

March 2017. This analysis assessed glycemic fluctuations and day-to-day blood glucose variability in patients treated with IDegLira compared with either insulin degludec (IDeg) or liraglutide alone. Investigators analyzed data from 2 randomized trials in patients with type 2 diabetes (T2D); in particular, 9-point self-monitored blood glucose (SMBG) profiles and continuous glucose monitoring (CGM) data from a patient subset.

Diabetic Retinopathy: A Position Statement by the American Diabetes Association

March 2017. The American Diabetes Association has updated its Position Statement on diabetic retinopathy for the first time since 2002. The update focuses on improvements in diabetic retinopathy assessment and treatment options, including optical coherence tomography to assess retinal thickness and intraretinal pathology and wide-field fundus photography to reveal clinically silent microvascular lesions. Improvements in medications and devices for systemic diabetes therapy are also discussed.

3 Years of Liraglutide vs Placebo for Type 2 Diabetes Risk Reduction and Weight Management in Individuals With Prediabetes

February 22, 2017. This randomized, controlled, double-blind trial evaluated the proportion of patients with prediabetes and obesity/overweight treated with liraglutide 3.0 mg vs placebo over a 3-year period to determine time to diabetes onset. Patients (N=2,254) from 191 clinical research sites were randomized 2:1; all were assigned to caloric restriction and increased physical activity. Fifty percent of patients completed the full study; patients who withdrew were not followed after discontinuation.