NCT00437164终止2 期
A Randomized, Double-blind, Parallel, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of Oral GW677954 Capsules (15 mg) in Combination With Insulin in Subjects With Type 2 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- changes in fluid related parameters as measured by hematocrit and hemoglobin levels and body weight
研究概览
简要总结
Many drugs used for the treatment of Type 2 Diabetes Mellitus cause the body to retain water. This study will assess whether or not GW677954 causes the body to retain fluid.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed by a doctor with Type 2 Diabetes Mellitus at least 3 months before Screening
- •Have a body mass index within range 25 to 40.0kg/m2 inclusive
- •Females who meet above criteria must be physiologically incapable of becoming pregnant (ie., surgically sterilized, or post-menopausal per protocol definition)
排除标准
- •Significant weight loss or gain in the 3 months before screening
- •Have used insulin to treat hyperglycemia within 3 months before screening
- •Have a history of fluid retention
- •Have uncontrolled high blood pressure
- •Have liver disease
- •Take loop diuretics (water pills), certain blood thinners, and/or St. Johns Wort. - Have or have had certain kinds of cancer
结局指标
主要结局
changes in fluid related parameters as measured by hematocrit and hemoglobin levels and body weight
时间窗: up to 24 weeks
次要结局
- safety/tolerability, as measured by adverse events, clinical laboratory, edema & glycemic measures, ophthalmic assessments; & changes in weight, waist & hip circumference(up to 24 weeks)
研究者
研究点 (2)
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