NCT00601250已完成3 期
A Randomised, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (One Dose, e.g. 5 mg), Administered Orally Once Daily Over 24 Weeks, With an Open Label Extension to 80 Weeks (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
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
- 701
- 试验地点
- 82
- 主要终点
- HbA1c Change From Baseline at Week 24
研究概览
简要总结
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin 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 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
Experimental
Patients receive linagliptin 5 mg tablets once daily
干预措施: linagliptin (Drug)
Placebo
Placebo Comparator
Patients receive placebo tablets matching linagliptin 5 mg tablets once daily
干预措施: linagliptin (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
- FPG Change From Baseline at Week 18(Baseline and week 18)
- HbA1c Change From Baseline at Week 18(Baseline and week 18)
- FPG Change From Baseline at Week 24(Baseline and week 24)
- 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)
- 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)
- Percentage of Patients With HbA1c<6.5% at Week 24(Baseline and week 24)
- Percentage of Patients Who Have a HbA1c Lowering by 0.5% at Week 24(Baseline and week 24)
- 2 Hour Post-Prandial Glucose (PPG) Increment Over Fasting Plasma Glucose (FPG) at Week 24(Baseline and week 24)
- HbA1c Change From Baseline at Week 6(Baseline and week 6)
- HbA1c Change From Baseline at Week 12(Baseline and week 12)
- Adjusted Means for 2h Post Prandial Blood Glucose (PPG) Change From Baseline at Week 24(Baseline and week 24)
研究者
研究点 (82)
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