NCT01755442终止1 期
A Phase 1, Double-blind, Randomized, 2-Way Crossover, Placebo-controlled Study to Investigate the Effect of AMG 151 on 24-hour Ambulatory Blood Pressure and Glucose Levels in Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Mean 24-hour systolic blood pressure
研究概览
简要总结
This is a phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to evaluate the effect of AMG 151 on 24-hour ambulatory blood pressure and glucose levels in subjects with type 2 diabetes mellitus who are on a stable regimen of metformin alone, metformin and a dipeptidyl peptidase-4 inhibitor (DPP4), metformin and a thiazolidinedione (TZD), or metformin, a DPP4, and a TZD for a minimum of 3 months prior to randomization.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 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
AMG 151
Active Comparator
干预措施: AMG 151 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Mean 24-hour systolic blood pressure
时间窗: After 14 days of AMG 151 or placebo treatment
次要结局
- 4-hour concentration time profile of glucose after the mixed meal tolerance test(After 13 days of AMG 151 or placebo treatment)
- Plasma glucose 2 hours after time 0 of mixed meal tolerance test(After 13 days of AMG 151 or placebo treatment)
- Mean 24-hour diastolic blood pressure(After 14 days of AMG 151 or placebo treatment)
- Mean 24-hour heart rate(After 14 days of AMG 151 or placebo treatment)
- 24-hour concentration time profile of glucose level from continuous glucose monitoring(Day 1 and day 14 of each period)
- Fasting plasma glucose and fructosamine(After 13 days of AMG 151 or placebo treatment)
- Safety end points will include the incidence of treatment emergent adverse events.(Up to 2 Months)
- Serum AMG 151 concentration(Up to 2 Months)
- Safety end points will include laboratory safety tests.(Up to 2 Months.)
- Safety end points will include vital signs.(Up to 2 Months)
- Safety end points will include ECGs.(Up to 2 Months)
研究者
研究点 (1)
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