NCT01084005已完成3 期
A Phase III Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of Linagliptin (5 mg) Administered Orally Once Daily Over 24 Weeks in Type 2 Diabetic Patients (Age >= 70 Years) With Insufficient Glycaemic Control( HbA1c >= 7.0) Despite Metformin and/or Sulphonylurea and/or Insulin Therapy
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
- 241
- 试验地点
- 34
- 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 linagliptin (5 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to stable treatment in elderly patients with T2DM 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
- 70 Years 至 —（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
Experimental
patients receive linagliptin 5 mg tablets once daily
干预措施: linagliptin (Drug)
placebo
Placebo Comparator
patients receive placebo tablets matching linagliptin 5 mg once daily
干预措施: placebo (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 prior use of insulin.
次要结局
- 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 24(Baseline and week 24)
- FPG Change From Baseline to Week 6(Baseline and week 6)
- FPG Change From Baseline to Week 12(Baseline and week 12)
- 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 Who Have a HbA1c Lowering by at Least 0.5% at Week 24(Baseline and week 24)
- Number of Patients With Rescue Therapy(week 24)
研究者
研究点 (34)
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