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. At baseline, 83.9% of patients were receiving insulin, mean patient age was 65.0 years, mean diabetes duration was 16.4 years, and mean (±SD) A1C level was 8.4 ± 1.7%. After 24 months, both groups had the same mean A1C level (7.5 ± 1.2%), but mean fasting plasma glucose was significantly lower in the degludec group (128 ± 56 vs 136 ± 57 mg per deciliter, P<0.001). The primary outcome occurred in 8.5% of patients in the degludec group vs 9.3% in the glargine group (hazard ratio [HR], 0.91; 95% confidence interval [CI], 0.78 to 1.06; P<0.001 for noninferiority). Severe hypoglycemia occurred in 4.9% of degludec patients and 6.6% of glargine patients; other adverse event rates did not differ between the two groups. Click here for full article