Top-line results from DURATION-6, a head-to-head study comparing investigational, weekly Bydureon™ (exenatide extended-release suncitaneous injection) to daily liraglutide (Victoza®) injection failed to meet the pre-specified primary endpoint of non-inferiority to liraglutide.

DURATION-6 is the sixth in a series of studies comparing Bydureon to other type 2 diabetes medications. It was a 26-week, open-label, superiority study in approximately 900 patients who were not achieving adequate HbA1c control with diet and exercise in conjunction with metformin, a sulfonylurea, metformin plus a sulfonylurea or metformin plus pioglitazone. The patients were randomised to exenatide 2mg once a week (n=461) or liraglutide forced titrated to 1.8mg daily (n=451). The primary endpoint was reduction in HbA1c. Patients on exenatide experienced a reduction in HbA1c of 1.3% from baseline, compared to a reduction of 1.5% for liraglutide, which did not meet the pre-specified primary endpoint of non-inferiority to liraglutide.

The New Drug Application for Bydureon was submitted to the FDA in 2009 and the Agency requested further data in October 2010. The companies plan to submit a response in the second half of 2011.