NCT00427401终止2 期
A Double Blind, Placebo Controlled, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-00915275 After Oral Administration To Subjects With Type 2 Diabetes Mellitus For 4-Weeks
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The primary end point is glucose lowering (24 hour mean glucose concentration).
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of PF-00915275 following administration to adult human subjects with T2DM for 4-weeks. The primary end point is glucose lowering (24 hour mean glucose concentration).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •HbA1c > 7.5%.
排除标准
- •Recent (within the past 12 months) evidence or history of unstable concomitant disease.
- •Treatment with any oral hypoglycemic agent within 3 months before enrollment.
- •The exception to these criteria is that subjects who are currently taking metformin hydrochloride, in a stable dose (that is no changes in dose) for treatment of their diabetes within the past 3 months or longer of enrollment may participate.
结局指标
主要结局
The primary end point is glucose lowering (24 hour mean glucose concentration).
次要结局
- Fasting blood glucose
研究者
研究点 (2)
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