Diabetes phase II study shows positive results

Monday, March 14, 2011 01:50 PM

Amylin Pharmaceuticals, Eli Lilly and Alkermes announced positive results from a phase II study evaluating the effects of a once-monthly injectable suspension formulation of exenatide on glycemic control in patients with type II diabetes.

This phase II, randomized, open-label study included 121 adults with type II diabetes who were not achieving adequate glucose control using diet and exercise alone or with a stable regimen of metformin, Actos (pioglitazone) or both. 

This phase II study assessed the efficacy, safety and tolerability of three different doses of exenatide once monthly. It also assessed exenatide once weekly (exenatide extended-release for injectable suspension, proposed brand name Bydureon), another investigational type II diabetes therapy. After 20 weeks of treatment (five injections), patients randomized to the exenatide once monthly treatment arms experienced average reductions in A1C ranging between 1.3% and 1.5% from baseline. In the once-weekly Bydureon treatment arm, the reduction was 1.5% points. A1C is a measure of average blood sugar over three months.

More than 90% of patients overall completed the study. The most common adverse events among the exenatide once monthly treatment groups were headache and nausea. Headache and diarrhea were most common among the once-weekly Bydureon group. No major or minor hypoglycemia was reported in the study.

This phase II, randomized, open-label study included 121 adults with type II diabetes who were not achieving adequate glucose control using diet and exercise alone or with a stable regimen of metformin, Actos (pioglitazone) or both. 

This phase II study assessed the efficacy, safety and tolerability of three different doses of exenatide once monthly. It also assessed exenatide once weekly (exenatide extended-release for injectable suspension, proposed brand name Bydureon), another investigational type II diabetes therapy. After 20 weeks of treatment (five injections), patients randomized to the exenatide once monthly treatment arms experienced average reductions in A1C ranging between 1.3% and 1.5% from baseline. In the once-weekly Bydureon treatment arm, the reduction was 1.5% points. A1C is a measure of average blood sugar over three months.

More than 90% of patients overall completed the study. The most common adverse events among the exenatide once monthly treatment groups were headache and nausea. Headache and diarrhea were most common among the once-weekly Bydureon group. No major or minor hypoglycemia was reported in the study.

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