NCT01517321已完成3 期
MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 6
- 主要终点
- Incidences of adverse experiences and change in vital sign, safety lab etc. as parameters of safety and tolerability
研究概览
简要总结
This Phase III clinical trial will examine the safety, tolerability, and efficacy of the addition of MK-0431/ONO-5435 to Japanese patients with Type 2 Diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue monotherapy.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue monotherapy
排除标准
- •Patients with Type 1 Diabetes Mellitus
研究组 & 干预措施
E
Experimental
干预措施: MK-0431/ONO-5435 (Drug)
P
Placebo Comparator
干预措施: Placebo, MK-0431/ONO-5435 (Drug)
结局指标
主要结局
Incidences of adverse experiences and change in vital sign, safety lab etc. as parameters of safety and tolerability
时间窗: 12 weeks and 52 weeks
次要结局
- HbA1c(12 weeks)
- 2-hour postmeal glucose(12 weeks)
- Fasting plasma glucose(12 weeks)
研究者
研究点 (6)
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