12 Week Randomised Double-blind BI 1356 2.5 mg Bid vs 5 mg qd add-on to Metformin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 491
- 试验地点
- 84
- 主要终点
- HbA1c Change From Baseline at Week 12
研究概览
简要总结
The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over 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
linagliptin low dose
linagliptin low dose twice daily
干预措施: linagliptin low dose (Drug)
placebo
placebo matching linagliptin
干预措施: placebo (Drug)
linagliptin medium dose
linagliptin medium dose once daily
干预措施: linagliptin medium dose (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 percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Treatment means are adjusted for baseline HbA1c and use of prior oral antidiabetics (OADs) in addition to background metformin.
次要结局
- The Occurrence of a Treat to Target Efficacy Response (HbA1c <6.5 %) After 12 Weeks of Treatment(12 weeks)
- HbA1c Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis(Baseline and week 6)
- HbA1c Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis(Baseline and week 12)
- FPG Change From Baseline at Week 12(Baseline and week 12)
- FPG Change From Baseline at Week 6 From Mixed Model Repeated Measures (MMRM) Analysis(Baseline and week 6)
- FPG Change From Baseline at Week 12 From Mixed Model Repeated Measures (MMRM) Analysis(Baseline and week 12)
- Percentage of Patients With HbA1c Lowering by 0.5% or More at Week 12(Week 12)
- Percentage of Patients With Rescue Therapy(12 weeks)
- The Occurrence of a Treat to Target Efficacy Response (HbA1c <7.0%) After 12 Weeks of Treatment(12 weeks)