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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 Not yet recruiting
Phase Phase 3
Start date April 30, 2018
Completion date April 2021

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


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