A Phase III Randomised, Double-blind, Placebo-controlled Parallel Group Study to Compare the Efficacy and Safety of Twice Daily Administration of the Free Combination of BI 1356 2.5 mg + Metformin 500 mg, or of BI 1356 2.5 mg + Metformin 1000 mg, With the Individual Components of Metformin (500 mg or 1000 mg Twice Daily), and BI 1356 (5.0 mg Once Daily) Over 24 Weeks in Drug Naive or Previously Treated (4 Weeks Wash-out and 2 Weeks Placebo run-in) Type 2 Diabetic Patients With Insufficient Glycaemic Control
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 857
- 试验地点
- 138
- 主要终点
- HbA1c Change From Baseline at Week 24
研究概览
简要总结
The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks
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
BI 1356 + metformin
BI 1356 low dose + metformin 500 mg, twice daily
干预措施: Bi 1356 + metformin (Drug)
matching placebo
matching placebo
干预措施: matching placebo (Drug)
BI 1356+ Metformin
BI 1356 low dose + metformin 1000 mg, twice daily
干预措施: Bi 1356 + metformin (Drug)
Metformin
Metformin 500 mg, twice daily
干预措施: metformin (Drug)
metformin
Metformin 1000 mg, twice daily
干预措施: metformin (Drug)
BI 1356
BI 1356 high dose, once daily
干预措施: BI 1356 (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)
- 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 2(Baseline and week 2)
- FPG Change From Baseline at Week 6(Baseline and week 6)
- FPG Change From Baseline at Week 12(Baseline and week 12)
- 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<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 Glucose (PPG) 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 24 for Open-label Patients(Baseline and week 24)
- FPG Change From Baseline at Week 24 for Open-label Patients(Baseline and week 24)
- Use of Rescue Therapy(24 weeks)
- Percentage of Patients With HbA1c Lowering by 0.5% at Week 24(Baseline and week 24)