NCT00530881已完成2 期
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine Safety and Establish Proof of Concept With PHX1149 in Patients With Type 2 Diabetes Mellitus
Phenomix1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2006年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- postprandial blood glucose
研究概览
简要总结
This will be a 4-week, multicenter, randomized, double-blind, parallel group, placebo-controlled, safety, tolerability, and efficacy study. Patients will be screened and be on one of three doses of PHX1149 (a new drug candidate for the treatment of Type 2 diabetes ) or placebo. The drug is a "DPP4 inhibitor"
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
- Triple (Participant, Care Provider, Investigator)
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 treatment with metformin +/- TZD
排除标准
- •Type 1 diabetes mellitus
研究组 & 干预措施
4
Placebo Comparator
干预措施: PHX1149 (Drug)
3 active, 1 placebo
Placebo Comparator
干预措施: PHX1149 (Drug)
结局指标
主要结局
postprandial blood glucose
次要结局
- fasting blood glucose, HbA1c, safety
研究者
研究点 (1)
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