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Clinical Trial Summary

Primary Objective:

-To demonstrate that, efpeglenatide doses 1 and 2 is noninferior to placebo on 3-point major adverse cardiac event (MACE) in Type 2 diabetes mellitus (T2DM) patients at high cardiovascular (CV) risk.

Secondary Objectives:

- To demonstrate that efpeglenatide doses 1 and 2 is superior to placebo in T2DM patients with high CV risk on the following parameters:

- 3-point MACE.

- Expanded CV outcome.

- Composite outcome of new or worsening nephropathy.

- To assess the safety and tolerability of efpeglenatide doses 1 and 2, both added to standard of care in T2DM patients at high CV risk.


Clinical Trial Description

The estimated study duration per participant is up to approximately 36 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03496298
Study type Interventional
Source Sanofi
Contact Trial Transparency email recommended (Toll free number for US &
Phone 800-633-1610
Email Contact-Us@sanofi.com
Status Recruiting
Phase Phase 3
Start date April 27, 2018
Completion date April 2021

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