NCT00430742终止3 期
A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Taranabant (MK0364) in Overweight and Obese Patients With Type 2 Diabetes Mellitus (T2DM) Followed by a 1-Year Extension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 600
- 主要终点
- Body weight at 36 weeks, HbA1c at 36 weeks
研究概览
简要总结
A worldwide study with extension in patients with type 2 diabetes mellitus to assess the safety and tolerability as well as the effects of treatment with an investigational drug for weight loss on body weight.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index (BMI) between 27 kg/m2 and 43 kg/m2 and HbA1c between 7.0% and 10%
排除标准
- •History of major psychiatric disorder
- •Blood pressure greater than 160/100
- •Use of any antihyperglycemic agent other than metformin
- •Triglycerides greater then 600 mg/dL
研究组 & 干预措施
2
Experimental
Arm 2: MK0364 1 mg capsule once daily
干预措施: Taranabant (Drug)
1
Experimental
Arm 1: MK0364 0.5 mg capsule once daily
干预措施: Taranabant (Drug)
3
Experimental
Arm 3: MK0364 2 mg capsule once daily
干预措施: Taranabant (Drug)
结局指标
主要结局
Body weight at 36 weeks, HbA1c at 36 weeks
时间窗: 36 weeks
次要结局
- Body weight at 24 and 52 weeks, HbA1c at 24 and 52 weeks(24 and 52 weeks)
研究者
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