Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)
3期
提前终止
NCT03713684
| 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 | 370 人 |
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| 干预（药物） | Efpeglenatide SAR439977, Background therapy |
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| 开始日期 | 2018年11月9日 |
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| 完成日期 | 2020年11月20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 basal insulin alone or in combination with oral antidiabetic drugs (OADs). 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 | -0.33 ± 1.09 percentage of HbA1c |
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| Efpeglenatide 2 mg | -1.27 ± 0.95 percentage of HbA1c |
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| Efpeglenatide 4 mg | -1.24 ± 0.96 percentage of HbA1c |
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| Efpeglenatide 6 mg | -1.43 ± 0.94 percentage of HbA1c |
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