NCT00396357已完成3 期
A Multicenter, Double-blind, Randomized Parallel-group, Study to Demonstrate the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd as add-on to Metformin 500 mg Bid Compared to Metformin 1000 mg Bid in Patients With Type 2 Diabetes Inadequately Controlled on Metformin 500 mg Bid 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
- 914
- 试验地点
- 2
- 主要终点
- Change from baseline in hemoglobin A 1 c (HbA1c) after 24 weeks of treatment
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid 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
- Triple (Participant, Care Provider, 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
- •18-78 years inclusive
- •Type 2 diabetes diagnosis at least 2 months prior to study entry
- •Body mass index in the range of 22-45 kg/m2
- •HbA1c in the range of 6.5 to 9% inclusive
- •Fasting plasma glucose <270 mg/dL (15 mmol/L)
排除标准
- •A history of type 1 diabetes
- •Evidence of significant diabetic complications
- •Treatment with insulin or any other oral antidiabetic agents
- •Congestive heart failure requiring pharmacologic treatment
- •Clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels >/= 1.5 mg/dl (males) and >/= 1.4 mg/dl (females)
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
vildagliptin + metformin
Experimental
干预措施: Vildagliptin (Drug)
Metformin
Active Comparator
干预措施: metformin (Drug)
结局指标
主要结局
Change from baseline in hemoglobin A 1 c (HbA1c) after 24 weeks of treatment
时间窗: 24 weeks
次要结局
- Gastrointestinal tolerability after 24 weeks of treatment(24 weeks)
- Change from baseline in fasting plasma glucose after 24 weeks(24 weeks)
- Adverse event profile after 24 weeks of treatment(24 weeks)
- Patients with endpoint HbA1c <7% and <6.5% after 24 weeks(24 weeks)
- Patients with reduction in HbA1c >0.7% after 24 weeks(24 weeks)
研究者
研究点 (2)
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