Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced positive results from a head-to-head study comparing exenatide once weekly, an investigational diabetes therapy, to BYETTA® (exenatide) injection taken twice daily, in patients with type 2 diabetes. After 24 weeks of treatment, patients taking exenatide once weekly experienced a statistically superior reduction in A1C, a measure of average blood sugar over three months, of 1.6 percentage points from baseline, compared to a reduction of 0.9 percentage points for BYETTA. Patients treated with exenatide once weekly achieved a mean A1C of 7.1 percent compared with a mean A1C of 7.7 percent in those treated with BYETTA. Both treatment groups achieved statistically significant weight loss by the end of the study, with an average loss of 5.1 pounds for patients taking exenatide once weekly and 3.0 pounds for patients taking BYETTA.
These findings are consistent with the results of other studies of exenatide once weekly and BYETTA. The companies conducted DURATION-5 to support regulatory submissions outside of the U.S. and provide additional controlled clinical data on the commercially manufactured product. DURATION is a series of clinical trials designed to test the superiority of exenatide once weekly as compared to currently available type 2 diabetes medications.
"The DURATION-5 data reinforce the efficacy of BYETTA and potential of exenatide once weekly in improving blood glucose control as measured by A1C, and build upon other successful DURATION trials," said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "More importantly, these results continue to suggest that if approved, exenatide once weekly could play an important role in advancing the treatment of type 2 diabetes by providing patients the opportunity for improved A1C control and weight loss with just one dose per week."