NCT00325117已完成3 期
A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 12 Weeks Treatment With Vildagliptin to Placebo as Add-on Therapy to Sulfonylurea in Patients With Type 2 Diabetes Inadequately Controlled With Sulfonylurea Monotherapy
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
- 200
- 试验地点
- 1
- 主要终点
- Change from baseline to endpoint on HbA1c at 12 weeks
研究概览
简要总结
This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 12-week clinical study is designed as a multicenter, randomized, double-blind, parallel-group, placebo-controlled study aimed to evaluate the efficacy and safety of vildagliptin as add-on therapy to a sulfonylurea in patients with type 2 diabetes inadequately controlled with sulfonylurea 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
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 of type 2 diabetes and treated with a stable dose of sulfonylurea
- •Patients on diet and exercise who have not reached target blood glucose levels
- •Outpatients
排除标准
- •Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
- •Significant cardiovascular complications as defined by the protocol
- •Significant diabetic complications as defined by the protocol
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Change from baseline to endpoint on HbA1c at 12 weeks
次要结局
- Adverse events profile after 12 weeks of treatment
- Change from baseline to endpoint on fasting plasma glucose at 12 weeks
- Change from baseline to endpoint in HOMA IR at 12 weeks
- Change from baseline to endpoint in HOMA B at 12 weeks
- Change from baseline to endpoint on fasting lipids at 12 weeks
研究者
研究点 (1)
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