Efficacy and Safety of Dulaglutide Versus Placebo and Exenatide in Type 2 Diabetes (AWARD-1)

This Phase 3, randomized, parallel-arm study compared efficacy and safety of 2 doses of dulaglutide (DU), a longacting GLP-1-receptoragonist, with exenatide (EX) or placebo (PL) in patients (pts) with type 2 diabetes treated with metformin (1500-3000 mg) and pioglitazone (30-45 mg). Pts [n = 976; mean baseline (BL) characteristics: age, 55.6 years; A1C, 8.1%; weight, 96.0 kg] were randomized (2:2:2:1 ratio) openly to twice-daily EX 10 μg or in a double- blind fashion to once-weekly DU 1.5 mg, DU 0.75 mg, or PL.