NCT00238498已完成2 期
A Clinical Study to Assess the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 291
- 主要终点
- Change from baseline in HbA1c at 12 weeks
研究概览
简要总结
This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of a number of doses of vildagliptin, an unapproved drug, in the treatment of people 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
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes
- •Patients who have been placed on diet and exercise therapy without achievement of glycemic control
- •Outpatients
排除标准
- •Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
- •Significant cardiovascular diseases
- •Significant diabetic complications
- •Other protocol-defined exclusion criteria may apply
结局指标
主要结局
Change from baseline in HbA1c at 12 weeks
次要结局
- Change from baseline in HOMA B at 12 weeks
- Change from baseline in HOMA IR at 12 weeks
- Change from baseline for postprandial glucose at 12 weeks
- Change from baseline on fasting plasma glucose at 12 weeks
- Change from baseline on postprandial glucose AUC at 12 weeks
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