SAN FRANCISCO, June 14, 2014 /PRNewswire/ -- For the first time today, Eli Lilly and Company (NYSE:LLY) and Boehringer Ingelheim Pharmaceuticals Inc. presented data showing that LY2963016, the alliance's investigational new insulin glargine product, has a similar safety and efficacy profile to currently marketed insulin glargine (Lantus(®)).(1,2,3,4,5,6) Results from these Phase I and Phase III studies were presented at the 74(th) American Diabetes Association Scientific Sessions in San Francisco.
"Results from six completed clinical trials for this new insulin glargine product showed that it works similarly in the body and produces clinical results similar to Lantus," said Tom Blevins, M.D., endocrinologist with Texas Diabetes & Endocrinology, Austin, TX. "These data are important because Lilly/BI's insulin glargine could serve as an important treatment option in the future when physicians are deciding on an insulin glargine product to help patients meet their treatment goals."
LY2963016 insulin glargine is an investigational basal insulin that is intended to provide long-lasting blood sugar control between meals and at night, an integral part of glycemic control.(7) It has the same amino acid sequence as Lantus(®) and, in most geographic regions, will be submitted for approval as a biosimilar. As the term 'biosimilar' is a regulatory designation, LY2963016 insulin glargine is considered a biosimilar in some regions but not in others, including the United States.
"Lilly and BI are pleased to share our new insulin glargine data with the medical community," said Gwen Krivi, Ph.D., vice president, Lilly Diabetes Development. "Our LY2963016 insulin glargine data package has been submitted for review to several global regulatory agencies, including the U.S., Europe and Japan. This is one step closer to providing an important insulin glargine option to physicians and patients."
Phase III Study Results
In patients with type 1 and type 2 diabetes, LY2963016 insulin glargine was compared to currently marketed insulin glargine, and both products led to significant decreases in average blood glucose levels (HbA1c). LY2963016 insulin glargine demonstrated non-inferiority compared to marketed insulin glargine, and marketed insulin glargine demonstrated non-inferiority to LY2963016 insulin glargine.(4,5)