A Phase III, Randomised, Double-blind, Placebo-controlled Parallel Group Safety and Efficacy Study of Linagliptin (5 mg Administered Orally Once Daily) Over 12 Weeks Followed by a 40 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Drug Naive or Previously Treated Type 2 Diabetic Patients With Moderate to Severe Renal Impairment and Insufficient Glycaemic Control
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 52
- 主要终点
- HbA1c Change From Baseline to Week 12
研究概览
简要总结
The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given over 12 weeks in drug naive or previously treated type 2 diabetic patients with moderate to severe renal impairment and insufficient glycaemic control. In addition safety in this patient population with longer term (40 week) treatment in comparison to sulfonylurea drug (glimepiride).
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 —（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
52 weeks treatment
干预措施: Placebo (Drug)
Linagliptin
52 weeks treatment
干预措施: Linagliptin (Drug)
Placebo
First 12 weeks of treatment
干预措施: Placebo (Drug)
Glimepiride
Placebo patients switch to glimepiride after 12 weeks (40 weeks treatment)
干预措施: Glimepiride (Drug)
Glimepiride
Placebo patients switch to glimepiride after 12 weeks (40 weeks treatment)
干预措施: Placebo (Drug)
结局指标
主要结局
HbA1c Change From Baseline to 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. Means are treatment adjusted for baseline HbA1c, renal function impairment and prior use of antidiabetic agents.
次要结局
- HbA1c Change From Baseline Over Time(Baseline, week 4, week 8, week 12, week 16, week 20, week 24, week 28, week 34, week 40, week 46, week 52)
- Fasting Plasma Glucose (FPG) Change From Baseline to Week 12(Baseline and week 12)
- Fasting Plasma Glucose (FPG) Change From Baseline Over Time(Baseline, week 4, week 8, week 12, week 20, week 24, week 28, week 34, week 40, week 46, week 52)
- Percentage of Patients With HbA1c <7.0%(Baseline, week 12 and week 52)
- Percentage of Patients With HbA1c <6.5%(Baseline, week 12 and week 52)
- Percentage of Patients Who Have a HbA1c Lowering by at Least 0.5%(Baseline, week 12 and week 52)
- Plasma Concentration of Linagliptin at Trough(Week 12, 24 and 52)