Both EASE trials of empagliflozin + insulin therapy met endpoints in adults with type 1 diabetes,- Eli Lilly + Boehringer.

Boehringer Ingelheim and Eli Lilly and Company announced that both randomized controlled trials in the EASE Phase III program, investigating the use of empagliflozin (Jardiance) in combination with insulin therapy in adults with type 1 diabetes, met their primary endpoint. The primary efficacy endpoint, defined in both trials as placebo-corrected change from baseline in A1C after 26 weeks of treatment, was met for all investigated doses of empagliflozin (2.5, 10 and 25 mg).

Type 1 diabetes currently affects 1.3 million adults in the U.S. and approximately 30 million adults worldwide. It is an autoimmune disease in which the body does not produce sufficient amounts of insulin, and therefore requires life-long daily insulin administration to regulate blood sugar. For some people with type 1 diabetes, it may be challenging to manage blood sugar levels with insulin alone. People with type 1 diabetes also face risks of complications such as sight loss, heart disease, kidney disease and amputations.

The safety profile in both studies was generally consistent with the previously reported safety profile of empagliflozin. The number of adjudicated diabetic ketoacidosis events was comparable between empagliflozin 2.5 mg and placebo and higher than placebo in adults with type 1 diabetes on empagliflozin 10 mg and 25 mg he full results from the EASE Phase III program will be presented at the European Association for the Study of Diabetes Annual Meeting on October 4, 2018, in Berlin, Germany.