NCT00532935已完成3 期
A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of the MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in 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
- 517
- 主要终点
- Change From Baseline in A1C at Week 32
研究概览
简要总结
A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes
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 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has type 2 diabetes mellitus
- •Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy
排除标准
- •Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
- •Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 12 weeks
- •Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 3 years
研究组 & 干预措施
1
Experimental
Sitagliptin phosphate (+) metformin hydrochloride
干预措施: sitagliptin phosphate (+) metformin hydrochloride (Drug)
结局指标
主要结局
Change From Baseline in A1C at Week 32
时间窗: Baseline and Week 32
A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent
次要结局
- Percent of Participants With A1C <7.0% at Week 32(Week 32)
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1(Baseline and Week 1)
- Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32(Baseline and Week 32)
- Change From Baseline in FPG at Week 32(Baseline and Week 32)
研究者
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