NCT00289848已完成3 期
A Multicenter, Double-Blind, Randomized, Placebo-Controlled 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
- 530
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18
研究概览
简要总结
This is a clinical study 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
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have Type 2 Diabetes Mellitus and have laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) >=7.5% and <=11% and a Fasting Plasma Glucose (FPG) >=130 mg/dL and <=280 mg/dL
- •Exclusion Criteria :
- •Patients have Type 1 Diabetes Mellitus or required insulin therapy within the past 12 months
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
sitagliptin 100 mg
干预措施: sitagliptin phosphate (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18
时间窗: Baseline and Week 18
A1C was measured as a 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 Fasting Plasma Glucose (FPG) at Week 18(Baseline and Week 18)
- Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18(Baseline and Week 18)
研究者
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