Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea
3期
提前终止
NCT03770728
| 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 | 312 人 |
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| 干预（药物） | Efpeglenatide SAR439977, Background therapy: Metformin alone or in combination with SU |
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| 开始日期 | 2019年8月1日 |
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| 完成日期 | 2020年11月28日 |
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| 结果公布日 | 2021年12月2日 |
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摘要
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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