Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise
Phase 3
Completed
NCT03353350
| Condition | Type 2 Diabetes Mellitus |
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| Phase | Phase 3 |
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| Sponsor | Hanmi Pharmaceutical Company Limited |
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| Status | Completed |
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| Enrollment | 406 participants |
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| Interventions | efpeglenatide (SAR439977) |
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| Start date | Dec 5, 2017 |
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| Completion date | Jan 29, 2020 |
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| Results posted | Jan 18, 2022 |
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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 T2DM (Type 2 Diabetes Mellitus) inadequately controlled with diet and exercise. 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 in Glycated Hemoglobin (HbA1c) (%)
Baseline to Week 30 · HbA1c (%)
| Placebo | -0.46 ± 1.16 HbA1c (%) |
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| Efpeglenatide 2 mg | -1.14 ± 0.96 HbA1c (%) |
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| Efpeglenatide 4 mg | -1.48 ± 1.01 HbA1c (%) |
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| Efpeglenatide 6 mg | -1.59 ± 1.04 HbA1c (%) |
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