Exenatide once monthly: Phase II data

An open-label, U.S. Phase II trial in 121 Type II diabetics showed that low-, mid- and high-dose subcutaneous exenatide once monthly reduced mean HbA1c from baseline to week 20 by 1.3-1.5% vs. 1.5% for 2 mg subcutaneous Bydureon exenatide once weekly. The most common adverse events for exenatide once monthly were headache and nausea, and no major or minor hypoglycemia or cases of pancreatitis were reported. The trial enrolled patients with Type II diabetes who were not achieving adequate HbA1c control with diet and exercise alone or in conjunction with a stable regimen of metformin and/or Actos pioglitazone from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502, Osaka, Japan). Based on the results, Amylin said it plans to meet with regulatory authorities to discuss the next steps for the exenatide once monthly program. Amylin and Eli Lilly co-developed both products, which use Medisorb drug delivery technology from Alkermes. ...