NCT00575471已完成2 期
A Randomized, Double-Blind, Placebo-Controlled 12-Week Dose-Response Study of Rivoglitazone (CS-011) in Patients With Type 2 Diabetes.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 250
- 主要终点
- Change in HbA1c from baseline for rivoglitazone compared to placebo
研究概览
简要总结
The purpose of this study is to assess the efficacy response of rivoglitazone HCl on the change in HbA1c after 12 weeks of treatment in patients with type 2 diabetes.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes mellitus
- •HbA1c >6.5% and <10%
- •FPG >126 mg/dL (7mmol/L) and <270 mg/dL (15 mmol/L)
排除标准
- •history of type 1 diabetes
- •history of ketoacidosis
- •current insulin therapy
- •C-peptide <0.5ng/mL
- •impaired hepatic function
- •CHF or history of CHF (NYHA stage I - IV)
- •uncontrolled hypertension
研究组 & 干预措施
1
Experimental
rivoglitazone HCl 0.5 mg tablets once daily for 12 weeks
干预措施: rivoglitazone HCl (Drug)
2
Experimental
rivoglitazone HCl 1 mg tablets once daily for 12 weeks
干预措施: rivoglitazone HCl (Drug)
3
Experimental
rivoglitazone HCl 1.5 mg tablets once daily for 12 weeks
干预措施: rivoglitazone HCl (Drug)
4
Placebo Comparator
Matching placebo tablets once daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in HbA1c from baseline for rivoglitazone compared to placebo
时间窗: 12 weeks
次要结局
- Change in Fasting Plasma Glucose from baseline for rivoglitazone HCl compared to placebo(12 weeks)
研究者
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