Once-Weekly Dulaglutide Non-Inferior to Liraglutide in Phase III Diabetes Trial
Hemoglobin A1c reduced at 26 weeks (February 25)
Positive results have been reported from the sixth AWARD (Assessment of Weekly AdministRation of LY2189265 in Diabetes) trial of once-weekly dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1) receptor agonist being studied as a treatment for type 2 diabetes.
AWARD-6 was a phase III, randomized, open-label, parallel-arm study comparing the effects of once-weekly dulaglutide and once-daily liraglutide on glycemic control in 599 patients with type 2 diabetes receiving concomitant metformin.
The study’s primary objective was to evaluate whether dulaglutide 1.5 mg, dosed once-weekly, was non-inferior to liraglutide 1.8 mg, dosed once-daily, in reducing hemoglobin A1c (HbA1c) from baseline at 26 weeks. Once-weekly dulaglutide 1.5 mg achieved this endpoint.
All of the previous five AWARD trials demonstrated superiority in reducing HbA1c at the 1.5 mg dose compared with placebo and active comparators.
Once-weekly dulaglutide has been submitted for FDA review.
Source: Eli Lilly; February 25, 2014.