ADA: Empagliflozin versus placebo controlled patients with type 2 diabetes on multiple daily insulin injections

In a 52-week study of obese adults with type 2 diabetes on high insulin doses with or without metformin, adding empagliflozin to multiple daily insulin injections significantly reduced blood glucose and body weight with lower insulin doses compared with placebo, according to data recently presented at the American Diabetes Association (ADA) Scientific Sessions in San Francisco.

In the placebo-controlled study, the safety and efficacy of empagliflozin 10 mg or 25 mg added onto multiple daily insulin injections, with or without metformin, was studied in obese adults with type 2 diabetes and inadequately controlled blood glucose levels. Mean baseline A_1c level for patients in this study was 8.3%.

After 18 weeks, empagliflozin 10 mg and 25 mg significantly reduced A_1c levels by 0.94% and 1.02%, respectively, compared with 0.50% with placebo. After 52 weeks, empagliflozin 10 mg and 25 mg significantly reduced A_1c by 1.18% and 1.27%, respectively, compared with 0.81% with placebo, indicating further A_1c reductions in both empagliflozin groups between 18 and 52 weeks.

After 52 weeks, patients in each of the empagliflozin arms also had an average body weight loss of 2 kg, compared with a gain of 0.4 kg for those in the placebo arm.

Hypoglycemia was reported in 51.1%, 57.7%, and 58.8% of patients in the empagliflozin 10 mg, 25 mg, and placebo arms, respectively.

“This new data adds to the clinical profile for empagliflozin and bolsters its large clinical registration program,” said Christophe Arbet-Engels, MD, PhD, vice president, metabolic-clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals.

Boehringer Ingelheim and Eli Lilly and Company sponsored the study.