Effect of Efpeglenatide on Cardiovascular Outcomes
Phase 3
Terminated
NCT03496298
| Condition | Type 2 Diabetes Mellitus |
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| Phase | Phase 3 |
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| Sponsor | Sanofi |
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| Status | Terminated |
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| Enrollment | 4,076 participants |
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| Interventions | Efpeglenatide (SAR439977) |
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| Start date | Apr 27, 2018 |
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| Completion date | Dec 10, 2020 |
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| Results posted | Oct 15, 2021 |
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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.
Time to First Occurrence of Major Adverse Cardiovascular Events (MACE): Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event - Non-Inferiority Analysis
From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months) · events per 100 participant-years
| Efpeglenatide 4 mg+6 mg | 3.9 events per 100 participant-years |
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| Placebo | 5.3 events per 100 participant-years |
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| p-value | <.0001 |
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| Hazard Ratio (HR) | 0.732 (95% CI 0.583–0.918) |
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