A Phase III, Randomised, Double-blind, Parallel Group, 24 Week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg and 25 mg Compared to Placebo, All Administered as Oral Fixed Dose Combinations With Linagliptin 5 mg, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks Treatment With Linagliptin 5 mg Once Daily on Metformin Background Therapy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 607
- 试验地点
- 90
- 主要终点
- HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment
研究概览
简要总结
This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy.
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
- 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
Linagliptin
5 mg once daily
干预措施: Linagliptin (Drug)
Linagliptin
5 mg once daily
干预措施: Empagliflozin placebo + Linagliptin placebo (Drug)
Empagliflozin + Linagliptin low dose
1 tablet once daily
干预措施: Empagliflozin + Linagliptin (Drug)
Empagliflozin + Linagliptin high dose
1 tablet once daily
干预措施: Empagliflozin + Linagliptin (Drug)
结局指标
主要结局
HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment
时间窗: Baseline and 24 weeks
Change from baseline in Glycated haemoglobin (HbA1c) \[%\] after 24 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The term 'baseline' was not used to refer to measurements before the administration of open-label medication.
次要结局
- Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment(Baseline and 24 weeks)
- Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment.(Baseline and 24 weeks)