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 Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 370
- 试验地点
- 47
- 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 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.
详细描述
Study duration per participant was approximately 64 weeks including an up to 2-week Screening Period, a 30-week Core Treatment Period, a 26-week Safety Extension 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
Efpeglenatide 2 mg
Participants received Efpeglenatide 2 milligrams (mg) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.
干预措施: Background therapy (Drug)
Placebo
Participants received placebo (matched to efpeglenatide) subcutaneous (SC) injection once weekly up to Week 56 on top of basal insulin alone or in combination with oral antidiabetic drugs (OADs).
干预措施: Placebo (Drug)
Placebo
Participants received placebo (matched to efpeglenatide) subcutaneous (SC) injection once weekly up to Week 56 on top of basal insulin alone or in combination with oral antidiabetic drugs (OADs).
干预措施: Background therapy (Drug)
Efpeglenatide 2 mg
Participants received Efpeglenatide 2 milligrams (mg) SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs.
干预措施: Efpeglenatide SAR439977 (Drug)
Efpeglenatide 4 mg
Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56.
干预措施: Efpeglenatide SAR439977 (Drug)
Efpeglenatide 4 mg
Participants received Efpeglenatide 4 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg and maintained at the 4 mg dose through-out the treatment duration up to Week 56.
干预措施: Background therapy (Drug)
Efpeglenatide 6 mg
Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56.
干预措施: Efpeglenatide SAR439977 (Drug)
Efpeglenatide 6 mg
Participants received Efpeglenatide 6 mg SC injection once weekly up to Week 56 on top of basal insulin alone or in combination with OADs. Participants initiated dosing at 2 mg once weekly up to Week 1; which was up titrated to 4 mg until Week 4 and later up-titrated to 6 mg and maintained at the 6 mg dose through-out the treatment duration up to Week 56.
干预措施: Background therapy (Drug)
结局指标
主要结局
Change From Baseline to Week 30 in HbA1c
时间窗: Baseline to Week 30
次要结局
- Change From Baseline to Week 56 in HbA1c(Baseline to Week 56)
- Change From Baseline to Week 30 in Fasting Plasma Glucose (FPG)(Baseline to Week 30)
- Change From Baseline to Week 30 and Week 56 in Body Weight(Baseline to Week 30 and Week 56)
- Number of Participants With HbA1c <7.0% at Week 30(Week 30)
- Number of Participants With At Least One Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL], and Severe Hypoglycemia)(Baseline up to Week 56)
- Number of Hypoglycemic Events (Documented Symptomatic Hypoglycemia <3.0 mmol/L [<54 mg/dL] and Severe Hypoglycemia) Per Participant-Year(Baseline up to Week 56)