Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
Фаза 3
Прекращено
NCT03684642
| 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 | 908 участн. |
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| Вмешательство | Efpeglenatide, Dulaglutide, Background therapy Metformin |
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| Дата начала | 26.09.2018 |
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| Дата завершения | 13.10.2020 |
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| Публикация результатов | 1.11.2021 |
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Кратко
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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