NCT00363948已完成3 期
MK-0431/ONO-5435 Phase III Clinical Study - Metformin Add-On Study for Patients With Type 2 Diabetes Mellitus
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
- 188
- 试验地点
- 8
- 主要终点
- tolerability
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of MK-0431/ONO-5435 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and metformin as 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes mellitus on diet/exercise therapy and metformin as monotherapy
排除标准
- •Patients with type 1 diabetes mellitus
研究组 & 干预措施
P
Placebo Comparator
干预措施: Placebo (Drug)
E
Experimental
干预措施: Sitagliptin phosphate (Drug)
结局指标
主要结局
tolerability
时间窗: 52 weeks
safety
时间窗: 52 weeks
HbA1c
时间窗: 12 weeks
次要结局
- Plasma glucose(12 weeks)
研究者
研究点 (8)
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