NCT00212641已完成2 期
Randomized Double-Blind Placebo-Controlled Pharmacodynamic Evaluation of ONO-5129 in Patients With Treatment Naive Type 2 Diabetes Mellitus
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 134
- 主要终点
- Fasting Blood Glucose at 8 weeks
研究概览
简要总结
The objectives of this study are to characterize the pharmacodynamic profile, safety and tolerability of ONO-5129 in patients with Type 2 Diabetes mellitus
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
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 Mellitus
- •FBG level > 140 mg/dL and < 270 mg/dL
- •Fasting TG level < 500 mg/dL
- •BMI of 22 to 40 kg/m2, inclusive
- •Other Inclusion criteria as specified in the study protocol
排除标准
- •Previous participation in an ONO-5129 protocol
- •Previous treatment with TZD agents or other current antidiabetics
- •History of myocardial infarction, coronary artery surgery, atrial/ventricular tachycardia, or atrial/ventricular fibrillation in the past six months
- •Presence of functional limitations due to cardiovascular disease in accordance with the New York Heart Association Classification System - Class III (moderate) or IV (severe)
- •Other exclusion criteria as specified in the study protocol
结局指标
主要结局
Fasting Blood Glucose at 8 weeks
次要结局
- Pharmacodynamic parameters at all time points
研究者
研究点 (134)
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