Amylin Pharmaceuticals, Inc. and Eli Lilly and Company announced results from the first double-blind, placebo-controlled clinical study to evaluate BYETTA(R) (exenatide) injection added to Lantus(R) (insulin glargine), which showed patients with type 2 diabetes achieved glucose targets without weight gain or increasing their risk of hypoglycemia. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association (ADA) in Orlando, Fla.
In the study, patients receiving insulin glargine, with or without oral agents, were randomized to receive BYETTA or placebo in addition to aggressive insulin titration. After 30 weeks of treatment, A1C decreased by 1.7 percentage points in patients adding BYETTA, compared with a decrease of 1.0 percentage point in patients treated with insulin alone. Weight decreased in patients adding BYETTA by 4 pounds, compared with an increase of 2 pounds in patients treated with insulin alone. Fasting plasma glucose and hypoglycemia were similar between treatment groups.
This study showed BYETTA may provide a complementary addition to basal insulin for hard-to-treat type 2 diabetes patients.
Results from this study will form the basis for a supplemental New Drug Application to the U.S. Food and Drug Administration. The filing is planned for the end of 2010.
Also presented at the ADA 70th Annual Scientific Sessions were final results from a retrospective study including more than 260,000 patients that showed the risk of acute pancreatitis among initiators of BYETTA(R) (exenatide) injection was not increased compared to initiators of other antidiabetic therapies.