A Randomised, Double-blind, Placebo Controlled, Parallel Group 24 Week Study to Assess the Efficacy and Safety of BI 1356 (5 mg) in Combination With 30 mg Pioglitazone (Both Administered Orally Once Daily), Compared to 30 mg Pioglitazone Plus Placebo in Drug Naive or Previously Treated 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
- 389
- 试验地点
- 43
- 主要终点
- HbA1c Change From Baseline to Week 24
研究概览
简要总结
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (Linagliptin) (5 mg / once daily) compared to placebo given for 24 weeks as initial combination therapy with pioglitazone 30 mg in patients with type 2 diabetes mellitus with insufficient glycaemic control.
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 (5 mg)
BI 1356 5mg in initial combination therapy with pioglitazone 30 mg
干预措施: Linagliptin + pioglitazone (30 mg) (Drug)
Placebo matching BI 1356 5 mg
Placebo in initial combination therapy with pioglitazone 30 mg
干预措施: placebo + pioglitazone (30 mg) (Drug)
结局指标
主要结局
HbA1c Change From Baseline to 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
- FPG Change From Baseline to 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 <6.5% at Week 24(Baseline and Week 24)
- HbA1c Change From Baseline to Week 6(Baseline and week 6)
- HbA1c Change From Baseline to Week 12(Baseline and week 12)
- HbA1c Change From Baseline to Week 18(Baseline and week 18)
- FPG Change From Baseline to Week 12(Baseline and week 12)
- FPG Change From Baseline to Week 6(Baseline and week 6)
- 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)
- FPG Change From Baseline to Week 24(Baseline and week 24)
- Percentage of Patients Who Have an HbA1c Lowering by 0.5% at Week 24(Baseline and Week 24)