NCT00998686终止3 期
A Phase 3, Randomized, Double-Blind, Active-Controlled, Multi-Center Extension Study to Evaluate Safety and Efficacy of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
Phenomix43 个研究点 分布在 6 个国家目标入组 650 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 650
- 试验地点
- 43
- 主要终点
- To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG
研究概览
简要总结
The purpose of this study is to demonstrate the safety and tolerability of dutogliptin over 52 weeks.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of all required visits of a qualifying Phase 3 core protocol
- •Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT302
排除标准
- •Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment
研究组 & 干预措施
dutogliptin/PHX1149T
Experimental
干预措施: dutogliptin (Drug)
sitagliptin
Active Comparator
干预措施: sitagliptin (Drug)
结局指标
主要结局
To demonstrate safety and tolerability of dutogliptin as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG
时间窗: 52 weeks
次要结局
- To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose(52 weeks)
研究者
研究点 (43)
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