NCT01089790终止3 期
A Phase III, Multicenter, Double-blind, Active-Controlled, 52 Week Extension Study to Evaluate the Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus Receiving Background Treatment With Glimepiride Alone or in Combination With Metformin or With Pioglitazone Alone
Forest Laboratories149 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2010年3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
- 141
- 试验地点
- 149
- 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
This study will evaluate the long-term safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 86 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have successfully completed all required visits of a qualifying Phase 3 core protocol
- •Be currently receiving treatment for T2DM as set forth in the qualifying Phase 3 core protocol
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
1
Experimental
干预措施: Dutogliptin (Drug)
2
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 (149)
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