NCT00854035已完成3 期
A Phase III, Randomized, Placebo-Controlled, Double-Blind Clinical Trial and Subsequent Open-Label, Extension Clinical Trial to Study the Efficacy and Safety of Addition of MK-0431/ONO-5435 in Japansese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Insulin Monotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 266
- 试验地点
- 7
- 主要终点
- HbA1c
研究概览
简要总结
This Phase III clinical trial will examine the efficacy, safety, and tolerability 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 insulin 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 insulin 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: MK-0431/ONO-5435 (Drug)
结局指标
主要结局
HbA1c
时间窗: 16 weeks
Safety and Tolerability
时间窗: 16 weeks and 52 weeks
次要结局
- 2 hour post-meal glucose(16 weeks)
- Fasting plasma glucose(16 weeks)
研究者
研究点 (7)
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