NCT00800683已完成3 期
Safety in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 vs. Placebo, DB, Parallel Group, Randomized, Insulin Background Inclusive
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
- 133
- 试验地点
- 53
- 主要终点
- HbA1c Change From Baseline at Week 12
研究概览
简要总结
to determine safety, efficacy and tolerability of BI 1356 versus placebo
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
Experimental
patient to receive a tablet containing BI 1356 once daily
干预措施: BI 1356 (Drug)
placebo
Placebo Comparator
patient to receive a tablet identical to BI 1356 once daily
干预措施: placebo (Drug)
结局指标
主要结局
HbA1c Change From Baseline at Week 12
时间窗: Baseline and Week 12
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
次要结局
- HbA1c Change From Baseline at Week 52(Baseline and Week 52)
- HbA1c Change From Baseline at Week 18(Baseline and Week 18)
- HbA1c Change From Baseline at Week 24(Baseline and Week 24)
- HbA1c Change From Baseline at Week 30(Baseline and Week 30)
- HbA1c Change From Baseline at Week 36(Baseline and Week 36)
- HbA1c Change From Baseline at Week 42(Baseline and Week 42)
- HbA1c Change From Baseline at Week 48(Baseline and Week 48)
- The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment(Baseline and Week 52)
- The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment(Baseline and Week 52)
- Percentage of Patients With HbA1c Lowering by 0.5% at Week 52(Baseline and Week 52)
- FPG Change From Baseline at Week 12(Baseline and Week 12)
- FPG 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 30(Baseline and Week 30)
- FPG Change From Baseline at Week 36(Baseline and Week 36)
- FPG Change From Baseline at Week 42(Baseline and Week 42)
- FPG Change From Baseline at Week 48(Baseline and Week 48)
- FPG Change From Baseline at week52(Baseline and Week 52)
- Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time(Baseline and Week 52)
- Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG(first administration of randomised treatment to ....)
研究者
研究点 (53)
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