A Randomized, Double-blind, Placebo-controlled, Five Parallel Group Study Investigating the Efficacy and Safety of BI 1356 BS (0.5 mg, 2.5 mg and 5.0 mg Administered Orally Once Daily) Over 12 Weeks in Drug Naive and Treated Patients With Type 2 Diabetes With Insufficient Glycemic Control (Study Includes an Open-label Metformin Treatment Arm)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 71
- 主要终点
- Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12
研究概览
简要总结
The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.
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
- 21 Years 至 75 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
Placebo
Placebo tablets matching BI 1356
干预措施: Placebo (Drug)
BI 1356 0.5 mg
BI 1356 dose 1 once daily
干预措施: BI 1356 dose 1 once daily (Drug)
BI 1356 2.5 mg
BI 1356 dose 2 once daily
干预措施: BI 1356 dose 2 once daily (Drug)
BI 1356 5.0 mg
BI 1356 dose 3 once daily
干预措施: BI 1356 dose 3 once daily (Drug)
Metformin
Metformin
干预措施: Metformin (Drug)
结局指标
主要结局
Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 12
时间窗: Baseline, week 12
The change from baseline reflects the Week 12 HbA1c minus the Week 0 HbA1c. Means are adjusted for baseline HbA1c.
次要结局
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12(Baseline, week 12)
- Percentage of Patients With Absolute Efficacy Response (HbA1c <= 7.0%) at 12 Weeks(Baseline, week 12)