NCT00099957已完成2 期
A Clinical Study to Assess the Effect of Vildagliptin on Postprandial Lipid Parameters 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
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Postprandial serum total triglycerides at 4 weeks
研究概览
简要总结
This study was not conducted in the United States. Many people with type 2 diabetes also have high cholesterol levels. The purpose of this study was to evaluate the effects of vildagliptin, an unapproved drug, on blood lipid measures such as triglycerides and cholesterol in 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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Blood glucose criteria must be met
- •Genetic markers associated with increased risk of cardiovascular disease
- •Not currently on drug therapy for type 2 diabetes
- •Body mass index (BMI) in the range 25-40
排除标准
- •Pregnancy or lactation
- •Type 1 diabetes
- •High cholesterol as defined by the protocol
- •Evidence of serious diabetic complications
- •Other protocol-defined exclusion criteria may apply
结局指标
主要结局
Postprandial serum total triglycerides at 4 weeks
次要结局
- Postprandial apo B-48 and apo B-100 in the two lipoprotein fractions - chylomicrons and VLDL1+VLDL2+IDL (VLDL/IDL) at 4 weeks
- Postprandial total cholesterol at 4 weeks
- Postprandial total apo B at 4 weeks
- Postprandial triglycerides in the two lipoprotein fractions - chylomicrons and VLDL1+VLDL2+IDL (VLDL/IDL) at 4 weeks
- Postprandial cholesterol in the two lipoprotein fractions - chylomicrons and VLDL1+VLDL2+IDL (VLDL/IDL) at 4 weeks
研究者
研究点 (1)
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