Efficacy and Safety of Dulaglutide Added on to Pioglitazone and Metformin Versus Exenatide in Type 2 Diabetes in a Randomized Controlled Trial (AWARD-1)

Clinical Trial News Tuesday, June 24th, 2014

Diabetes Care: May 30, 2014

Objective To compare efficacy and safety of dulaglutide, a once weekly glucagon-like peptide1 receptor agonist, to placebo and exenatide in type 2 diabetes patients. Primary objective was superiority of dulaglutide 1.5 mg versus placebo in HbA1cchange at 26 weeks.

Research Design and Methods This 52-week, multicenter, parallel-arm study (primary endpoint: 26 weeks) randomized patients (2:2:2:1) to dulaglutide 1.5 mg, dulaglutide 0.75 mg, exenatide 10 μg, or placebo (placebo-controlled period: 26 weeks). Patients were treated with metformin (1500-3000 mg) and pioglitazone (30-45 mg); mean baseline HbA1c was 8.1% (65 mmol/mol). Read more

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