NCT01101945终止2 期
An Open Label, Multi-Center, Long-Term Follow-up Study to Evaluate the Safety of PHX1149T in Subjects With Type 2 Diabetes Mellitus - Extension to Protocol PHX1149-PROT202
Phenomix55 个研究点 分布在 4 个国家目标入组 339 人开始时间: 2007年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 339
- 试验地点
- 55
- 主要终点
- To demonstrate safety and tolerability of dutogliptin/PHX1149T as assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments
研究概览
简要总结
The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Completed Visit 7/Day 98 of the core protocol PHX1149-PROT202
- •Current treatment of Type 2 diabetes mellitus in accordance with product labeling with metformin, or thiazolidinedione (TZD), or metformin + TZD
排除标准
- •Inadequately controlled Type 2 diabetes mellitus with need for therapy with insulin
结局指标
主要结局
To demonstrate safety and tolerability of dutogliptin/PHX1149T as assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments
时间窗: 104 weeks
To demonstrate safety and tolerability of dutogliptin/PHX1149Tas assessed by vital signs, adverse event reporting, and routine clinical laboratory assessments
时间窗: 208 weeks (U.S. only)
次要结局
- To demonstrate maintenance or lowering of HbA1c and fasting blood glucose(104 weeks)
研究者
研究点 (55)
Loading locations...
相似试验
终止
3 期
Long-term Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes MellitusType 2 DiabetesType 2 Diabetes MellitusNCT00865592Phenomix450
已完成
3 期
Long-term Safety Study of Vildagliptin in Patients With Type 2 DiabetesType 2 DiabetesNCT01159249Novartis Pharmaceuticals245
终止
3 期
Safety and Efficacy Study of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of MetforminType 2 Diabetes MellitusNCT00998686Phenomix650
已完成
2 期
Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis ParticipantsRheumatoid ArthritisNCT02065700Galapagos NV739
已完成
3 期
A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302Short Bowel SyndromeNCT03268811Shire9