A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Once Weekly Exenatide Therapy Added to Titrated Basal Insulin Glargine Compared to Placebo Added to Titrated Basal Insulin Glargine in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Glargine With or Without Metformin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 464
- 试验地点
- 1
- 主要终点
- Change in HbA1c From Baseline to Week 28
研究概览
简要总结
Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added to titrated basal insulin glargine with or without metformin to placebo added to titrated basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the 28-week treatment 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 130 Years（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
Exenatide
Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
干预措施: Exenatide (Drug)
Placebo
Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
干预措施: Exenatide matching placebo (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to Week 28
时间窗: Baseline to Week 28
To compare the change from baseline in HbA1c achieved with exenatide once weekly (EQW) added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. SU= sulfonylurea.
次要结局
- Percentage of Participants Achieving HbA1c <7.0% at Week 28(Baseline to Week 28)
- Change in Body Weight From Baseline to Week 28(Baseline to Week 28)
- Percentage of Participants Achieving HbA1c <7.0% at Week 28, No Weight Gain at Week 28, and No Major Hypoglycemia Over 28 Weeks(Baseline to Week 28)
- Change in Seated Systolic Blood Pressure From Baseline to Week 28(Baseline to Week 28)
- Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test (MTT)(Baseline to Week 28)
- Change From Baseline to Week 28 in Daily Insulin Dose(Baseline to Week 28)