NCT00996658已完成3 期
A Phase III, Randomised, Double Blind, Placebo Controlled Parallel Group Efficacy and Safety Study of Linagliptin 5 mg Administered Orally Once Daily Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite a Therapy of Metformin in Combination With Pioglitazone
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
- 278
- 试验地点
- 52
- 主要终点
- Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks
研究概览
简要总结
The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (5 mg once daily) compared to placebo given for 24 weeks as add on therapy to metformin in combination with pioglitazone in 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 79 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
Linagliptin
Experimental
Linagliptin tablets once daily
干预措施: Linagliptin (Drug)
Placebo
Placebo Comparator
Placebo tablets once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks
时间窗: baseline, 24 weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
次要结局
- Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks(24 weeks)
- Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks(baseline, 6 weeks)
- Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks(baseline, 12 weeks)
- Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks(baseline, 18 weeks)
- Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks(24 weeks)
- Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks(24 weeks)
- Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks(baseline, 24 weeks)
- Change From Baseline in Fasting Plasma Glucose (FPG) After 6 Weeks(baseline, 6 weeks)
- Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks(baseline, 12 weeks)
- Change From Baseline in Fasting Plasma Glucose (FPG) After 18 Weeks(baseline, 18 weeks)
研究者
研究点 (52)
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