Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea
Phase 3
Terminated
NCT03770728
| 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 | 312 participants |
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| Interventions | Efpeglenatide SAR439977, Background therapy: Metformin alone or in combination with SU |
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| Start date | Aug 1, 2019 |
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| Completion date | Nov 28, 2020 |
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| Results posted | Dec 2, 2021 |
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Summary
Primary Objective: To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo in glycated hemoglobin (HbA1c) change in participants with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin alone or in combination with sulfonylurea (SU). Secondary Objectives: * To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo on glycemic control. * To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to placebo on body weight. * To evaluate the safety of once weekly injection of efpeglenatide.
Change From Baseline to Week 30 in HbA1c
Baseline to Week 30 · percentage of HbA1c
| Placebo | -0.27 ± 0.92 percentage of HbA1c |
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| Efpeglenatide 2 mg | -1.05 ± 0.88 percentage of HbA1c |
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| Efpeglenatide 4 mg | -1.46 ± 0.90 percentage of HbA1c |
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| Efpeglenatide 6 mg | -1.36 ± 1.09 percentage of HbA1c |
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