NCT02897349已完成3 期
A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of Linagliptin, Administered Orally Once Daily, in Combination With Insulin Therapy for 24 Weeks in Chinese Type 2 Diabetes Mellitus Patients With Insufficient Glycaemic Control
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 25
- 主要终点
- Percentage Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment
研究概览
简要总结
To evaluate the efficacy and safety of linagliptin compared to placebo when added on to insulin therapy alone or in combination with metformin in Chinese 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
- 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
Experimental
干预措施: linagliptin (Drug)
linagliptin
Experimental
干预措施: background therapy (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
Placebo
Placebo Comparator
干预措施: background therapy (Drug)
结局指标
主要结局
Percentage Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment
时间窗: Baseline and week 24
Percentage change from baseline, that is, \[\[(HbA1c after 24 weeks of treatment) - (HbA1c at baseline)\] / (HbA1c at baseline)\] \*100%, where baseline refers to the last observation prior to the start of randomised study drug, including the observation prior to the placebo run-in.
次要结局
- Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment(Baseline and week 24)
- Change From Baseline in 2-hour (2-h) Postprandial Plasma Glucose (PPG) After 24 Weeks of Treatment(Baseline and week 24)
- Percentage of Participants With HbA1c on Treatment <7.0 Percentage (%) After 24 Weeks of Treatment(24 weeks)
- Percentage of Participants With HbA1c on Treatment < 6.5% After 24 Weeks of Treatment(24 weeks)
- Percentage of Participants With HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment(24 weeks)
- Percentage of Participants With Any Investigator-defined Hypoglycaemic Adverse Event (AE) With Plasma Glucose (PG) ≤70 mg/dL(24 weeks)
- Percentage of Participants With Any Severe Hypoglycaemic AE(24 weeks)
研究者
研究点 (25)
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