A 52-week Randomised, Double-blind, Parallel Group, Safety and Efficacy Study of Empagliflozin Once Daily as add-on Therapy to Glucagon-like Peptide-1 Receptor Agonist in Japanese Type 2 Diabetes Mellitus Patients With Insufficient Glycaemic Control
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 16
- 主要终点
- Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment
研究概览
简要总结
This is a multi-center, randomised, double-blind, parallel-group, safety and efficacy study of empagliflozin as add-on to GLP-1 RA in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control
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
入排标准
- 年龄范围
- 20 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
empagliflozin 10 mg
empagliflozin 10 mg tablet and placebo matching empagliflozin 25 mg tablet
干预措施: empagliflozin 10mg (Drug)
empagliflozin 10 mg
empagliflozin 10 mg tablet and placebo matching empagliflozin 25 mg tablet
干预措施: Placebo (Drug)
empagliflozin 25 mg
empagliflozin 25 mg tablet and placebo matching empagliflozin 10 mg tablet
干预措施: empagliflozin 25 mg (Drug)
empagliflozin 25 mg
empagliflozin 25 mg tablet and placebo matching empagliflozin 10 mg tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment
时间窗: 52 weeks
Percentage of patients with drug-related Adverse events (AEs) during 52 weeks of treatment are presented
次要结局
- Change From Baseline in HbA1c After 52 Weeks of Treatment(baseline and 52 weeks)