A 30-week, Multicenter, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of Efpeglenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Alone or in Combination With Sulfonylurea
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 312
- 试验地点
- 48
- 主要终点
- Change From Baseline to Week 30 in HbA1c
研究概览
简要总结
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.
详细描述
Study duration per participant was approximately 39 weeks including an up to 3-week Screening Period, a 30-week Treatment Period, and a 6-week safety Follow-up Period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Participants received placebo (matched to Efpeglenatide) subcutaneous (SC) injection once weekly up to Week 30 on top of metformin alone or in combination with SU.
干预措施: Placebo (Drug)
Efpeglenatide 2 mg
Participants received Efpeglenatide 2 milligrams (mg) SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU.
干预措施: Efpeglenatide SAR439977 (Drug)
Efpeglenatide 4 mg
Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and was maintained at the 4 mg dose through-out the treatment duration, up to Week 30.
干预措施: Efpeglenatide SAR439977 (Drug)
Efpeglenatide 6 mg
Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 30 on top of metformin alone or in combination with SU. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 3 and later up-titrated to 6 mg and was maintained at the 6 mg dose through-out the treatment duration, up to Week 30.
干预措施: Efpeglenatide SAR439977 (Drug)
结局指标
主要结局
Change From Baseline to Week 30 in HbA1c
时间窗: Baseline to Week 30
This analysis included all Week 30 assessment values available.
次要结局
- Change From Baseline to Week 30 in Body Weight(Baseline to Week 30)
- Number of Participants With HbA1c <7.0%(Week 30)
- Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year(Baseline up to Week 30)
- Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG)(Baseline to Week 30)
- Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], Severe Hypoglycemia)(Baseline up to Week 30)