Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

Summary

Primary Objective: To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with T2DM (Type 2 Diabetes Mellitus) inadequately controlled with diet and exercise. Secondary Objectives: * To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison to placebo on glycemic control * To demonstrate the superiority of once-weekly injection of efpeglenatide in comparison to placebo on body weight * To evaluate the safety of once-weekly injection of efpeglenatide

Timeline

Start

2017-12-05

Primary completion

2020-01-29

Completion

2020-09-07

Outcome

Met primary endpoint

paper Least squares mean HbA1c reductions from baseline were statistically superior for each efpeglenatide dose versus placebo (2 mg, -0.5% [95% CI -0.9, -0.2; P = 0.0054]; PMID 35671039 ↗

Publications

• Frias JP, Choi J, Rosenstock J, Popescu L, Niemoeller E, Muehlen-Bartmer I, Baek S. Efficacy and Safety of Once-Weekly Efpeglenatide Monotherapy Versus Placebo in Type 2 Diabetes: The AMPLITUDE-M Randomized Controlled Trial. Diabetes Care. 2022 Jul 7;45(7):1592-1600. doi: 10.2337/dc21-2656.

Drugs

Indications