BASINGSTOKE, England, March 10, 2011 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. , Eli Lilly and Company and Alkermes, Inc. today announced positive results from a phase 2 study evaluating the effects of a once-monthly injectable suspension formulation of exenatide on glycaemic control in patients with type 2 diabetes.
The 121-patient phase 2 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(R)), another investigational type 2 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 percentage points from baseline. In the exenatide once-weekly treatment arm, the reduction was 1.5 percentage points. A1C is a measure of average blood sugar over three months.
More than 90 percent of patients overall completed the study. The most common adverse events among the exenatide once monthly treatment groups were headache and nausea. Headache and diarrhoea were most common among the exenatide once-weekly group. No major or minor hypoglycaemia was reported in the study.
Based on the encouraging results of this study, the companies plan to proceed with regulatory interactions to outline the next steps for this important programme.
Exenatide once monthly is a new, extended-release formulation of exenatide, the active ingredient in Byetta(R) (exenatide) injection, which is given twice daily. Exenatide once-monthly is based on the same Medisorb(R) microsphere technology used in exenatide once-weekly.
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This phase 2, randomized, open-label study included 121 adults with type 2 diabetes who were not achieving adequate glucose control using diet and exercise alone or with a stable regimen of metformin, pioglitazone, or both. Subjects were randomized to receive either 2 mg weekly subcutaneous injections of exenatide once-weekly or subcutaneous injections of exenatide once-monthly at a low, medium or high dose, each administered once every four weeks, for a total of 20 weeks.