NCT00486291已完成2 期
A Phase 2, Randomized, Double Blind, Parallel Design Study Comparing the Efficacy and Safety of VI-0521 to Placebo in the Glycemic Management of Obese Diabetic Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- VIVUS LLC
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Change From Baseline in HbA1c at Week 28.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of VI-0521 compared to placebo in the glycemic management of obese diabetic adults.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Type 2 Diabetes
- •BMI 27-42
- •Specified diet/exercise and/or diabetes medications
排除标准
- •BP > 150/95
- •Stroke/MI/unstable cardiovascular disease within 6 months
- •Clinically significant renal, hepatic, or psychiatric disease
- •Unstable thyroid disease or replacement therapy
- •Nephrolithiasis
- •Obesity of known genetic or endocrine origin
- •Participation in a formal weight loss program or lifestyle intervention
- •History of glaucoma
- •Pregnancy or breastfeeding
- •Alcohol abuse
- •Eating disorder
- •Excluded medications
研究组 & 干预措施
1
Experimental
Phentermine 15mg/topiramate 100mg
干预措施: VI-0521 (Drug)
2
Placebo Comparator
Matched placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in HbA1c at Week 28.
时间窗: Baseline to 28 weeks
次要结局
- Absolute Weight Change (kg) From Baseline to Week 28(Baseline to 28 weeks)
研究者
研究点 (1)
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