NCT00143520已完成2 期
A Randomized, Double-blind, Double-dummy, Placebo-controlled 26-week Dose-response Study of Rivoglitazone HCl (CS-011) With Active Comparator (Pioglitazone HCl) in Subjects With Type 2 Diabetes
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 441
- 试验地点
- 74
- 主要终点
- Change in HbA1c
研究概览
简要总结
This is a 6-month study to evaluate the effects of monotherapy with rivoglitazone, an insulin sensitizer, on glycemic control in newly identified type 2 diabetics or diabetics not adequately treated with other antidiabetic agents. The study tests rivoglitazone and uses a placebo and active treatment group for comparison.
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
- •Type 2 diabetes in male or female patients
- •Between 18 and 75 years of age
- •With a HbA1c greater than or equal to 7.5% and less than 10.5% at randomization
排除标准
- •Type 1 diabetics or type 2 diabetics currently on insulin therapy
- •Patients unwilling or unable to discontinue their anti-diabetic medication(s)
- •History of ketoacidosis
- •History of therapy with rosiglitazone, troglitazone, pioglitazone
结局指标
主要结局
Change in HbA1c
次要结局
- FPG, Lipids, hsCRP, Adiponectin
研究者
研究点 (74)
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