NCT00737633终止2 期
An Open-Label, Non-Randomized Multicenter Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Providing and Maintaining Glycemic Control in Type 2 Diabetic Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- VIVUS LLC
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Change in HbA1c From Baseline to Week 72
研究概览
简要总结
This study is an extension of a study that has been ongoing for 1 year. The purpose of this open label study is to see the how well type 2 diabetics respond to VI-0521(phentermine/topiramate) in controlling blood sugar and how safe VI-0521 is over an extended period of time. All subjects eligible to enroll into this study will receive study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have completed the qualifying DM-230 trial
- •If females of child-bearing potential, subjects must be using adequate contraception
- •Provide written informed consent
- •Be willing and able to comply with scheduled study visits, treatment plan, lab tests and other study procedures
- •Be greater than 80% compliant in study medication use during the last three visits for DM-230
排除标准
- •Subjects who have developed one or more morbidities during the DM-230 trial that would pose a safety concern
研究组 & 干预措施
16-Week population
Experimental
Placebo subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
干预措施: VI-0521 (Drug)
72-Week population
Experimental
Active treatment subjects in OB-202 (NCT00486291) and DM-230 (NCT00600067)
干预措施: VI-0521 (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to Week 72
时间窗: Baseline to 72 weeks
次要结局
- Percent Weight Change From Baseline to Week 72(Baseline to 72 weeks)
研究者
研究点 (1)
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