completed

The objective of AMPLITUDE-O was to:

i Demonstrate that efpeglenatide (4 or 6 mg weekly) is noninferior to placebo on 3-point major adverse cardiac event (MACE) in high-risk people with Type 2 diabetes mellitus (T2DM) and cardiovascular and/or renal disease.

ii Demonstrate that efpeglenatide (4 or 6 mg weekly) is superior to placebo in people with T2DM on the following parameters: 3-point MACE; MACE, revascularization or unstable angina,; a renal composite outcome; and other cardiovascular outcomes.

Dr. Gerstein, global study chair of AMPLITUDE-O, was assisted by PHRI statisticians Leanne Dyal, Laura Heenan, Chinthanie Ramasundarahettige, Olga Shestakovska, and Purnima Rao-Melacini.

Study Type

Interventional - Drug

Study Design

Double-blind, Placebo-controlled, Parallel-group RCT

NO. of Countries

28

NO. of Sites

344

NO. of Participants

4076

Study Period

2018-2020

Sponsor

Sanofi

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