NCT00621140已完成3 期
A Randomised, Double-blind, Placebo-controled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug Naive or Previously Treated (6 Weeks Washout) Type 2 Diabetic Patients With Insufficient Glycemic 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
- 503
- 试验地点
- 69
- 主要终点
- HbA1c Change From Baseline at Week 24
研究概览
简要总结
To investigate efficacy, safety and tolerability of BI 1356 versus placebo
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 80 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 5 mg
Experimental
linagliptin 5 mg once daily
干预措施: linagliptin (Drug)
placebo
Placebo Comparator
placebo matching linagliptin 5 mg tablets
干预措施: placebo (Drug)
结局指标
主要结局
HbA1c Change From Baseline at Week 24
时间窗: Baseline and week 24
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
次要结局
- HbA1c Change From Baseline at Week 6(Baseline and week 6)
- HbA1c Change From Baseline at Week 12(Baseline and week 12)
- FPG Change From Baseline at Week 6(Baseline and week 6)
- FPG Change From Baseline at Week 12(Baseline and week 12)
- Percentage of Patients With HbA1c <7.0% at Week 24(Baseline and week 24)
- FPG Change From Baseline at Week 24(Baseline and week 24)
- Percentage of Patients With HbA1c<6.5% at Week 24(Baseline and week 24)
- HbA1c Change From Baseline at Week 18(Baseline and week 18)
- FPG Change From Baseline at Week 18(Baseline and week 18)
- Percentage of Patients With HbA1c<7.0% at Week 24(Baseline and week 24)
- Percentage of Patients With HbA1c <6.5% at Week 24(Baseline and week 24)
- Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24(Baseline and week 24)
- Percentage of Patients With HbA1c Lowering by 0.5% at Week 24(Baseline and week 24)
研究者
研究点 (69)
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