Efficacy and Safety of Dulaglutide Added Onto Pioglitazone and Metformin Versus Exenatide in Type 2 Diabetes (AWARD-1)

The AWARD-1 trial (Assessment of Weekly AdministRation of LY2189265 in Diabetes-1) was a phase III, randomized, double-blind study that compared two doses of dulaglutide (0.75 mg and 1.5 mg weekly) with exenatide (10 µg twice daily) and placebo in 976 patients with type 2 diabetes inadequately controlled with metformin and pioglitazone, over 52 weeks.

Primary results demonstrated clear superiority of dulaglutide 1.5 mg, with a mean HbA1c reduction of -1.51%, compared to -0.99% with exenatide and -1.30% with dulaglutide 0.75 mg (p<0.001 for both doses vs. placebo). The proportion of patients achieving HbA1c <7% was 78% in the dulaglutide 1.5 mg group versus 52% in the exenatide group.

Regarding adverse effects, nausea and diarrhea were the most common across all active treatment groups, but the incidence of hypoglycemia was low and similar between groups. Dulaglutide also promoted weight loss, although less than that observed with exenatide.

This study was pivotal in establishing dulaglutide as a weekly administration therapeutic option in the GLP-1 agonist arsenal, offering significant dosing convenience with glycemic efficacy superior to twice-daily exenatide.