NCT00094757已完成3 期
A Multicenter, Randomized, Double-Blind Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
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
- 521
- 主要终点
- Change From Baseline in A1C at Week 18
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of an investigational drug 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 (Participant, Investigator)
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
- •Patients at least 18 years of age and not older than 75 who have a specific type of diabetes called Type 2 Diabetes Mellitus
排除标准
- •Younger than 18 years of age or older than 75
- •Any condition, which in the opinion of the investigator, may not be in the patient's best interest to participate
研究组 & 干预措施
Sitagliptin 100 mg
Experimental
Sitagliptin 100 mg
干预措施: Comparator: sitagliptin 100 mg (Drug)
Sitagliptin 200 mg
Experimental
Sitagliptin 200 mg
干预措施: Comparator: sitagliptin 200 mg (Drug)
Placebo/Pioglitazone
Placebo Comparator
Placebo/Pioglitazone
干预措施: Comparator: placebo (Drug)
Placebo/Pioglitazone
Placebo Comparator
Placebo/Pioglitazone
干预措施: Comparator: pioglitazone (Drug)
结局指标
主要结局
Change From Baseline in A1C at Week 18
时间窗: Weeks 0-18
Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
次要结局
- Change From Baseline in FPG at Week 18(Weeks 0-18)
- Change From Baseline in FPG at Week 54(Weeks 0-54)
- Change From Baseline in A1C at Week 54(Weeks 0-54)
研究者
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