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news.Amylin Pharmaceuticals, Eli Lilly and Alkermes have announced positive results from a 30-week comparator study of their once-weekly exenatide long-acting release injection and Byetta injection taken twice-daily in patients with type 2 diabetes.
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The 30-week, open-label, noninferiority study included 295 subjects with type 2 diabetes who were not achieving adequate glucose control using diet and exercise with or without the use of one or more oral anti-diabetic agents.
Once-weekly exenatide, a long-acting version of Amylin’s diabetes drug Byetta, showed a statistically significant improvement in A1C of approximately 1.9% from baseline, compared to an improvement of approximately 1.5% for Byetta. Approximately three out of four subjects treated with once-weekly exenatide achieved an A1C of 7%, which is the target for good glucose control as recommended by the American Diabetes Association.
After 30 weeks of treatment, both once-weekly exenatide and Byetta resulted in an average weight loss of approximately eight pounds. The companies anticipate a regulatory submission to the FDA by the end of the first half of 2009.