NCT00819091已完成3 期
A Randomized, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 18 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control (HbA1c 7.0-10%) Despite Background Therapy With a Sulfonylurea Drug.
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
- 245
- 试验地点
- 45
- 主要终点
- Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18
研究概览
简要总结
Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.
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
Active Comparator
5 mg orally (po) once daily
干预措施: BI 1356 (Drug)
Placebo
Placebo Comparator
one tablet once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in HbA1c (Glycosylated Hemoglobin) at Week 18
时间窗: Baseline, week 18
HbA1c is measured as a percent. The change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent. Means are adjusted for baseline HbA1c and previous anti-diabetic medication.
次要结局
- Change From Baseline in Fasting Plasma Glucose at Week 18(Baseline, week 18)
- Change From Baseline in Fasting Plasma Glucose at Week 12(Baseline, week 12)
- Percentage of Patients With Absolute Efficacy Response (HbA1c < 7%) at Week 18(week 18)
- Percentage of Patients With Absolute Efficacy Response (HbA1c < 6.5%) at Week 18(week 18)
- Percentage of Patients With HbA1c Lowering by at Least 0.5% From Baseline at Week 18(Baseline, week 18)
- Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 6(Baseline, week 6)
- Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 12(Baseline, week 12)
- Mixed Model Repeated Measurements Analysis of Change From Baseline in HbA1c at Week 18(Baseline, week 18)
- Change From Baseline in Fasting Plasma Glucose at Week 6(Baseline, week 6)
研究者
研究点 (45)
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