NCT00383578已完成3 期
A Multicenter, Randomized, Double-Blind, Active Controlled Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd or Metformin 1500 mg Daily in Elderly Drug Naive Patients With Type 2 Diabetes
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
- 335
- 试验地点
- 2
- 主要终点
- Change from baseline in HbA1c
研究概览
简要总结
This study is designed to demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive 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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 65 years to the upper age limit recommended by local prescribing information for metformin
- •Drug naive patients with type 2 diabetes.
- •Body mass index (BMI) in the range of 22-40 kg/m
- •HbA1c in the range of 7 to 9% inclusive
- •FPG <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
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Metformin
Active Comparator
干预措施: Metformin 1500 mg daily (Drug)
Vildagliptin
Experimental
干预措施: Vildagliptin 100 mg qd (Drug)
结局指标
主要结局
Change from baseline in HbA1c
时间窗: after 24 weeks of treatment
次要结局
- Adverse event profile(after 24 weeks of treatment)
- Gastrointestinal tolerability(after 24 weeks of treatment)
- Patients with endpoint HbA1c <7% and patients with reduction in HbA1c > 0.7%(after 24 weeks of treatment)
- Change from baseline in fasting plasma glucose(after 24 weeks of treatment)
- Change from baseline in body weight(after 24 weeks of treatment)
研究者
研究点 (2)
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