NCT00290940已完成2 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of CS-917 as Monotherapy for 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
- 400
- 试验地点
- 66
- 主要终点
- Mean change from baseline in HbA1C after 12 weeks compared to placebo
研究概览
简要总结
This study will compare glucose lowering with CS-917 compared to placebo after 3 months of treatment
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Drug naive or newly diagnosed type 2 diabetic subjects:
- •Never received oral antihyperglycemic or insulin therapy or
- •No oral antihyperglycemic or insulin therapy for more than 6 months since original diagnosis and
- •No insulin therapy within one year of screening, with the exception of use during hospitalization or for use in gestational diabetes and
- •No antihyperglycemic therapy for more than three consecutive days, or a total of of seven non-consecutive days, during the 8 weeks prior to screening.
- •HbA1C>6.7% and < or = to 10% at screening
排除标准
- •Current insulin therapy
- •Symptoms of poorly controlled diabetes
- •History of diabetic ketoacidosis or hyperosmolar, nonketonic coma within one year of screening
- •Serum bicarbonate < or = to 19 meq/L
- •Serum creatinine (Scr) > 1.4 mg/dL (females) or 1.5 mg/dL (males)
- •Contraindication to metformin
结局指标
主要结局
Mean change from baseline in HbA1C after 12 weeks compared to placebo
次要结局
- Onset of efficacy of CS-917
- Safety and tolerability of CS-917
- Changes in other relevant glycemic and metabolic measures
- Proportion of subjects achieving therapeutic response
- Proportion of subjects discontinuing or requiring rescue for continued or worsening hyperglycemia
研究者
研究点 (66)
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