NCT00335712已完成2 期
Phase II Study of ONO-5129 in Patients With 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
- 81
- 试验地点
- 2
- 主要终点
- Fasting Blood Glucose at week 8
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics 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
- 45 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fasting Blood Glucose 126-250mg/dL
- •HbA1c 6.5-11%
排除标准
- •Previous treatment with antidiabetic agents equal to or less than 2-3 months prior to randomization
- •History of myocardial infarction, coronary artery surgery
- •Other eligibility criteria as specified in the study protocol
结局指标
主要结局
Fasting Blood Glucose at week 8
次要结局
- Other glycemic control parameters (e.g., HbA1c, glycoalbumin)
研究者
研究点 (2)
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