NCT00389415已完成3 期
A Multicenter, Open, Long Term Safety Study of 52 Weeks Treatment With Vildagliptin (100 mg qd) In Patients With Type 2 Diabetes (Extension Study of Study CLAF237A1303)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Adverse events profile after 52 weeks of treatment
研究概览
简要总结
This 52-week multicenter open-labeled extension study is designed to assess the long-term safety of vildagliptin (100 mg qd) in patients with Type 2 Diabetes. This extension study is open to patients who have completed core study CLAF237A1303.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis as Type 2 Diabetes
- •Patients who have completed study CLAF237A1303
- •Outpatients
排除标准
- •Patients who prematurely discontinued Study CLAF237A1303
- •Other protocol-defined inclusion/exclusioncriterial may apply
结局指标
主要结局
Adverse events profile after 52 weeks of treatment
次要结局
- Change from baseline to endpoint on HbA1c at 52 weeks
- Change from baseline to endpoint on fasting plasma glucose at 52 weeks
- Change from baseline to endpoint in HOMA B at 52 weeks
- Change from baseline to endpoint in HOMA IR at 52 weeks
- Change from baseline to endpoint in body weight at 52 weeks
研究者
研究点 (1)
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