NCT03496298

Effect of Efpeglenatide on Cardiovascular Outcomes

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Efpeglenatide on Cardiovascular Outcomes in Type 2 Diabetes Patients at High Cardiovascular Risk

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,076 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high cardiovascular (CV) risk. Secondary Objectives: To demonstrate that efpeglenatide 4 and 6 mg was superior to placebo in T2DM participants 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 4 and 6 mg, both added to standard of care in T2DM participants at high CV risk.

Detailed description

The study duration per participant was up to approximately 36 months.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Efpeglenatide (SAR439977)	Pharmaceutical form: Solution for injection, Route of administration: SC
DRUG	Placebo	Pharmaceutical form: Solution for injection Route of administration: SC

Timeline

• Start date: 2018-04-27
• Primary completion: 2020-12-10
• Completion: 2020-12-10
• First posted: 2018-04-12
• Last updated: 2021-10-15
• Results posted: 2021-10-15

Locations

353 sites across 28 countries: United States, Argentina, Bulgaria, Canada, Chile, Denmark, Estonia, Finland, Germany, Hungary, India, Italy, Latvia, Lithuania, Mexico, Norway, Peru, Poland, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study