A 28-week, Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study With a 24-week Extension Phase Followed by a 52-week Extension Phase to Evaluate the Efficacy and Safety of Simultaneous Administration of Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg Compared to Exenatide Once Weekly 2 mg Alone and Dapagliflozin Once Daily 10 mg Alone in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 695
- 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 D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter, Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD) compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes who have inadequate glycemic control on metformin.
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 Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg
干预措施: Exantide with Dapagliflozin (Drug)
Exenatide Once Weekly 2 mg Alone
干预措施: Exentide (Drug)
Dapagliflozin Once Daily 10 mg Alone
干预措施: Dapagliflozin (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 to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
次要结局
- Change in Body Weight From Baseline to Week 28(Baseline to Week 28)
- Change in Fasting Plasma Glucose From Baseline to Week 2(Baseline to Week 2)
- Percentage of Patients Achieving HbA1c <7% at Week 28(Baseline to Week 28)
- Change in Systolic Blood Pressure From Baseline to Week 28(Baseline to Week 28)
- Change in Fasting Plasma Glucose 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(Baseline to Week 28)
- Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28(Baseline to Week 28)