Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
3期
提前终止
NCT03684642
| 适应症 | Type 2 Diabetes Mellitus |
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| 分期 | 3期 |
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| 申办方 | Sanofi |
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| 状态 | 提前终止 |
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| 受试者人数 | 908 人 |
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| 干预（药物） | Efpeglenatide, Dulaglutide, Background therapy Metformin |
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| 开始日期 | 2018年9月26日 |
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| 完成日期 | 2020年10月13日 |
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| 结果公布日 | 2021年11月1日 |
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摘要
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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