Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. announced results from DURATION-4, the fourth in a series of studies designed to test the superiority of Bydureon (exenatide extended-release for injectable suspension), an investigational type 2 diabetes therapy, as compared to other type 2 diabetes medications.
The 26-week clinical study compared Bydureon monotherapy to Januvia(R) (sitagliptin), Actos(R) (pioglitazone HCI) or metformin, three oral type 2 diabetes medications commonly prescribed early in the treatment of type 2 diabetes. Study participants were not achieving adequate A1c control using diet and exercise, and were not on any diabetes therapy when they entered the study. After 26 weeks of treatment, patients randomized to Bydureon experienced a reduction in A1c of 1.5 percentage points from baseline, which was significantly greater than the reduction of 1.2 percentage points for Januvia. Patients randomized to metformin experienced a reduction in A1c of 1.5 percentage points, and patients receiving Actos experienced a reduction of 1.6 percentage points. Patients receiving Bydureon, Actos and metformin treatment achieved an average A1c of less than 7 percent by study end.
Treatment with Bydureon produced an average weight loss of 4.5 pounds, which was statistically significantly greater than the average 1.7 pounds patients lost with Januvia and the average 3.3 pounds patients gained with Actos. Patients receiving metformin experienced an average weight loss of 4.4 pounds.
Bydureon is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide – the active ingredient in Byetta – in a single weekly dose.