A Phase III, Randomised, Double-blind, Parallel Group, 52 Week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin and Linagliptin Fixed Dose Combination Compared With Linagliptin Plus Placebo in Japanese Type 2 Diabetes Mellitus Patients With Insufficient Glycaemic Control After 16 Weeks Treatment With Once Daily Linagliptin 5 mg.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 275
- 试验地点
- 40
- 主要终点
- Change of Glycosylated Haemoglobin A1c (Glycosylated Haemoglobin A1c After 24 Weeks of Double-blind Treatment From Baseline)
研究概览
简要总结
This trial will compare the use of fixed dose combination of empagliflozin and linagliptin to linagliptin alone in patient with type 2 diabetes mellitus
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
- 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
Linagliptin
patient to receive 5 mg linagliptin once daily
干预措施: Linagliptin (Drug)
Linagliptin
patient to receive 5 mg linagliptin once daily
干预措施: Empagliflozin placebo + linagliptin placebo low dose (Drug)
Linagliptin
patient to receive 5 mg linagliptin once daily
干预措施: Empa + lina highdose placebo (Drug)
Empagliflozin + linagliptin low dose
patient to receive one tablet once daily
干预措施: Empagliflozin + linagliptin low dose (Drug)
Empagliflozin + linagliptin low dose
patient to receive one tablet once daily
干预措施: Linagliptin placebo (Drug)
Empagliflozin + linagliptin high dose
patient to receive one tablet once daily
干预措施: Linagliptin placebo (Drug)
Empagliflozin + linagliptin high dose
patient to receive one tablet once daily
干预措施: Empagliflozin + linagliptin high dose (Drug)
Linagliptin placebo
干预措施: Empagliflozin + linagliptin low dose (Drug)
Linagliptin placebo
干预措施: Linagliptin placebo (Drug)
Linagliptin placebo
干预措施: Empagliflozin + linagliptin high dose (Drug)
Empagliflozin + linagliptin high dose placebo
干预措施: Linagliptin (Drug)
Empagliflozin + linagliptin high dose placebo
干预措施: Empa + lina highdose placebo (Drug)
Empagliflozin + linagliptin low dose placebo
干预措施: Linagliptin (Drug)
Empagliflozin + linagliptin low dose placebo
干预措施: Empagliflozin placebo + linagliptin placebo low dose (Drug)
结局指标
主要结局
Change of Glycosylated Haemoglobin A1c (Glycosylated Haemoglobin A1c After 24 Weeks of Double-blind Treatment From Baseline)
时间窗: Baseline and 24 week
Change from baseline in Glycosylated haemoglobin A1c (HbA1c) at Week 24 was calculated as: HbA1c at Week 24 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented.
次要结局
- Change in HbA1c From Week 28 at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Only)(28 Week (pre up-titration) and 52 Week)
- Change in HbA1c From Baseline at Week 52 (All Empagliflozin Versus All Placebo)(Baseline and 52 week)
- Change in HbA1c From Baseline at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Versus Linagliptin 5 mg + Placebo 25 mg)(Baseline and 52 week)
- Change in HbA1c From Baseline at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Versus All Placebo)(Baseline and 52 week)