Weekly doses of the Type 2 diabetes drug exenatide resulted in better glucose control than twice-daily injections, a 30-week comparative study found. The twice-daily injected product is marketed under the trade name Byetta.
The study, sponsored by Amylin Pharmaceuticals, Eli Lilly and Alkermes, found a statistically significant improvement of approximately 1.9 percentage points from baseline in the glucose measure A1C among patients taking exenatide weekly compared with an improvement of approximately 1.5 percentage points for those taking the twice-daily injection.
Approximately three-quarters of subjects treated with weekly exenatide achieved an A1C of 7 percent or less, thereby meeting the target for good glucose control recommended by the American Diabetes Association.
After 30 weeks of treatment, both treatments resulted in an average weight loss of approximately 8 pounds. Almost 90 percent of subjects in both groups completed the study, which enrolled patients not achieving adequate glucose control with either diet and exercise or oral glucose-lowering agents.
The sponsors said they expect to make a regulatory submission for the weekly dose to the FDA by mid-2009.
FDAnews Drug Daily Bulletin | Nov. 8, 2007 | Vol. 4 No. 220
Labels: Byetta, exenatide
