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)
Фаза 3
Прекращено
NCT03713684
| Заболевание | Type 2 Diabetes Mellitus |
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| Фаза | Фаза 3 |
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| Спонсор | Sanofi |
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| Статус | Прекращено |
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| Участники | 370 участн. |
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| Вмешательство | Efpeglenatide SAR439977, Background therapy |
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| Дата начала | 9.11.2018 |
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| Дата завершения | 20.11.2020 |
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| Публикация результатов | 2.12.2021 |
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Кратко
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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