Randomized, Three Period Cross Over, Double Blind, Double Dummy Study in Type 2 Diabetic Patients to Assess the Endothelial Effects of Linagliptin, Glimepiride and Placebo Therapy for 28 Days ('ENDOTHELINA')
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change From Baseline in Flow Mediated Vasodilation (FMD) Under Fasted Condition on Day 28
研究概览
简要总结
The general aim of the present study is to investigate the impact of 4 weeks treatment with linagliptin (5 mg) on endothelial function in patients with type 2 diabetes mellitus. In the current trial this effect of linagliptin treatment on endothelial function will be compared against both the sulfonylurea glimepiride and against placebo, which has not been tested in a trial before; as also is the case for other DPP-4 inhibitors.
Besides placebo, glimepiride was chosen as a comparator, as it is one compound of the second most used oral antidiabetic drug class.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 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 5mg
given once daily over 28 days
干预措施: Placebo (Drug)
Linagliptin 5mg
given once daily over 28 days
干预措施: Linagliptin (Drug)
Glimepiride
given once daily in 1mg dosis over 7 days, following a titration step to 2mg and application for 21 days
干预措施: Placebo (Drug)
Glimepiride
given once daily in 1mg dosis over 7 days, following a titration step to 2mg and application for 21 days
干预措施: Glimepiride (Drug)
Placebo
given once daily over 28 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Flow Mediated Vasodilation (FMD) Under Fasted Condition on Day 28
时间窗: baseline and day 28 for each treatment arm
Endothelial function under fasted condition was measured with flow mediated vasodilation (FMD). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.
次要结局
- Change From Baseline in Flow Mediated Vasodilation (FMD) 2 h Post Meal on Day 28(baseline and day 28 for each treatment arm)
- Change From Baseline in 2 Hours Post Meal Endothelial Independent Vasodilation (EIDV) on Day 28(baseline and day 28 for each treatment arm)
- Number of Patients With Adverse Events(up to 20 weeks)