NCT00106704已完成3 期
A Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Glimepiride Alone or in Combination With Metformin
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
- 441
- 主要终点
- Change From Baseline in A1C at Week 24
研究概览
简要总结
The purpose of this clinical study is to determine the safety and efficacy 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
- Crossover
- 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 with Type 2 Diabetes Mellitus with inadequate glycemic control
排除标准
- •Patients with Type 1 Diabetes Mellitus
研究组 & 干预措施
Placebo/ Pioglitazone
Placebo Comparator
Placebo tablet daily for 24 weeks followed by Pioglitazone tablet daily for 30 weeks
干预措施: Comparator: Placebo (Drug)
Placebo/ Pioglitazone
Placebo Comparator
Placebo tablet daily for 24 weeks followed by Pioglitazone tablet daily for 30 weeks
干预措施: Comparator: Pioglitazone (Drug)
Sitagliptin
Experimental
Sitagliptin 10 mg tablet daily for 54 weeks
干预措施: Comparator: Sitagliptin (Drug)
结局指标
主要结局
Change From Baseline in A1C at Week 24
时间窗: Baseline and 24 Weeks
Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
次要结局
- Change From Baseline in FPG at Week 24(Baseline and 24 Weeks)
研究者
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