NCT00541775已完成3 期
A Multicenter, Double-Blind, Placebo and Active Controlled, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg Once Daily in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
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
- 273
- 主要终点
- Hemoglobin A1C (A1C) at Week 18
研究概览
简要总结
The purpose of this study is to test the safety and effectiveness of sitagliptin 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient has Type 2 diabetes
- •Currently taking metformin >1500 mg/day for at least 10 weeks
- •Male or female
排除标准
- •Patient has peripheral edema
- •History of type 1 diabetes
- •Patient required insulin within prior 8 weeks
- •Have participated or are currently participating in another study with an investigational compound or device within 12 weeks of starting this study
- •Participating in a weight loss program
研究组 & 干预措施
Sitagliptin
Experimental
sitagliptin 100 mg
干预措施: Sitagliptin (Drug)
结局指标
主要结局
Hemoglobin A1C (A1C) at Week 18
时间窗: Baseline and 18 Weeks
A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. The study hypothesis comparison was between sitagliptin versus placebo.
次要结局
- 2-hour Post-meal Glucose (PMG) at Week 18(Baseline and 18 Weeks)
- Fasting Plasma Glucose (FPG) at Week 18(Baseline and 18 Weeks)
研究者
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