Boehringer Ingelheim and Eli Lilly and Company announced that both randomized controlled trials in the EASE Phase III program, investigating the use of empagliflozin 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.
“Despite recent advances in insulin therapy and patient care, less than one third of adults with type 1 diabetes in the U.S. consistently meet target blood sugar levels,” noted Thomas Seck, M.D., vice president of Clinical Development and Medical Affairs – Primary Care, Boehringer Ingelheim Pharmaceuticals, Inc. “The EASE trials are part of our comprehensive clinical development program exploring how empagliflozin may improve patient health outcomes and fill treatment gaps for adults with and without type 2 diabetes, and we look forward to sharing the full results from both trials.”
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.
The 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.
Empagliflozin is currently not approved for use in people with type 1 diabetes. Boehringer Ingelheim and Lilly are discussing next steps and exploring regulatory options.
(Source: Eli Lilly and Company)
Filed Under: Drug Discovery