A 56-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 Diet and Exercise
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 406
- 试验地点
- 54
- 主要终点
- Change in Glycated Hemoglobin (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 T2DM (Type 2 Diabetes Mellitus) inadequately controlled with diet and exercise.
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 is approximately 65 weeks, including a 3-week screening period, 30 weeks core treatment period, 26 weeks extension treatment period, and 6 weeks safety follow up.
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
Efpeglenatide 2mg
Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks
干预措施: efpeglenatide (SAR439977) (Drug)
Efpeglenatide 4 mg
Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)
干预措施: efpeglenatide (SAR439977) (Drug)
Efpeglenatide 6 mg
Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period)
干预措施: efpeglenatide (SAR439977) (Drug)
Placebo
Matching placebo (Prefilled syringe) administered once weekly for 56 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Change in Glycated Hemoglobin (HbA1c) (%)
时间窗: Baseline to Week 30
Change from Baseline to Week 30 in HbA1c
次要结局
- Hypoglycemic Events(Baseline to Week 56)
- Change in Body Weight at Week 56(Baseline to Week 56)
- Change in HbA1c (%)(Baseline to Week 56)
- HbA1c <7%(Week 30)
- Change in Body Weight at Week 30(Baseline to Week 30)
- Hypoglycemic Participants(Baseline to Week 56)
- Change in Fasting Plasma Glucose (FPG)(Baseline to Week 30)
- Treatment Emergent Adverse Events (TEAEs)(Baseline to Week 56)