NCT00728351已完成3 期
A Multicenter, Double-blind, Randomized Study to Compare the Efficacy of 24 Weeks Treatment With Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) Versus Metformin Monotherapy (1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With 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
- 317
- 试验地点
- 45
- 主要终点
- HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy
研究概览
简要总结
The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.
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
- •History of T2DM treated with Metformin
排除标准
- •FPG >= 260 mg/dL (14.4mmol/L)
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
vildagliptin + metformin
Experimental
干预措施: vildagliptin + metformin (Drug)
metformin
Active Comparator
干预措施: metformin (Drug)
结局指标
主要结局
HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy
时间窗: 24 weeks
次要结局
- Body weight change from baseline(24 weeks)
- Safety and tolerability(24 weeks)
- FPG reduction(24 weeks)
- Changes in the fasting lipid profile(24 weeks)
研究者
研究点 (45)
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