Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
Phase 3
Terminated
NCT03684642
| 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 | 908 participants |
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| Interventions | Efpeglenatide, Dulaglutide, Background therapy Metformin |
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| Start date | Sep 26, 2018 |
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| Completion date | Oct 13, 2020 |
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| Results posted | Nov 1, 2021 |
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Summary
Primary Objective: To demonstrate the non-inferiority of once weekly injection of efpeglenatide in comparison to once weekly injection of dulaglutide on glycated hemoglobin (HbA1c) change in participants with Type 2 diabetes mellitus (T2DM) inadequately controlled with metformin. Secondary Objectives: * To demonstrate the superiority of once weekly injection of efpeglenatide with once weekly injection of dulaglutide on glycemic control. * To demonstrate the superiority of once weekly injection of efpeglenatide with once weekly injection of dulaglutide on body weight. * To evaluate the safety of once weekly injection of efpeglenatide and once weekly injection of dulaglutide.
Change From Baseline to Week 56 in HbA1c
Baseline to Week 56 · percentage of HbA1c
| Efpeglenatide 4 mg | -1.12 ± 0.06 percentage of HbA1c |
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| Efpeglenatide 6 mg | -1.17 ± 0.06 percentage of HbA1c |
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| Dulaglutide 1.5 mg | -1.09 ± 0.06 percentage of HbA1c |
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| Least Square (LS) Mean difference | -0.03 (95% CI -0.20–0.14) |
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