A Randomised, db, Placebo-controlled, Parallel Group Efficacy and Safety Study of BI 1356 (5mg), Administered Orally Once Daily for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients With Insufficient Glycaemic Control for Whom Metformin Therapy is Inappropriate (Intolerability or Contraindication)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 53
- 主要终点
- HbA1c Change From Baseline at Week 18 (Interim Analysis)
研究概览
简要总结
Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride)
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
52 week treatment
干预措施: Linagliptin (Drug)
Placebo
First 18 weeks of treatment
干预措施: Linagliptin Placebo (Drug)
Glimepiride
Placebo patients switch to glimepiride week19-52
干预措施: Glimepiride (Drug)
结局指标
主要结局
HbA1c Change From Baseline at Week 18 (Interim Analysis)
时间窗: Baseline and week 18
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance.
HbA1c Change From Baseline at Week 18 (Final Analysis)
时间窗: Baseline and week 18
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c, prior OADs and reason for metformin intolerance. The primary analysis was re-run at the completion of the study in the final study report.
次要结局
- Fasting Plasma Glucose (FPG) Change From Baseline at Week 18 (Interim Analysis)(Baseline and week 18)
- Percentage of Patients With HbA1c<7.0 at Week 18 (Interim Analysis)(Week 18)
- Percentage of Patients With HbA1c<6.5 at Week 18 (Interim Analysis)(Week 18)
- Percentage of Patients With HbA1c Lowering by 0.5% at Week 18 (Interim Analysis)(Week 18)
- The Change in HbA1c From Baseline by Visit Over Time(Baseline and weeks 6,12, 18, 22, 26, 30, 34, 40, 46, 52)
- The Change in FPG From Baseline by Visit Over Time(Baseline and weeks 6,12,18, 22, 26, 30, 34, 40, 46, 52)