NCT00865592终止3 期
An Open Label, Multi-Center, Long-Term Extension Study to Evaluate the Safety of PHX1149T/Dutogliptin in Subjects With Type 2 Diabetes Mellitus
Phenomix69 个研究点 分布在 7 个国家目标入组 450 人开始时间: 2009年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 450
- 试验地点
- 69
- 主要终点
- To demonstrate safety and tolerability of dutogliptin
研究概览
简要总结
The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.
详细描述
In this study, open-label dutogliptin/PHX1149T will be offered to subjects who complete a Phase 3 core protocol and wish to continue treatment with dutogliptin. This will allow for the collection of long-term safety data and will also demonstrate long-term effects on HbA1c and fasting blood glucose.
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 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 (e.g., Visit 8/Day 196 of PHX1149-PROT301)
- •Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT301
排除标准
- •Except for Type 2 diabetes, any other uncontrolled, serious pulmonary, cardiovascular, hematologic, renal, gastrointestinal, endocrine, neurological, proliferative, immunosuppressive, psychiatric, or urogenital disorder; or diseases of skin and its appendages, the eyes, ears, nose, or throat
- •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
结局指标
主要结局
To demonstrate safety and tolerability of dutogliptin
时间窗: Two years
次要结局
- To demonstrate maintenance or lowering of HbA1c(Two years)
- To demonstrate maintenance or lowering of fasting blood glucose(Two years)
研究者
研究点 (69)
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