NCT00380445已完成3 期
Effect of Vildagliptin on Adipose Tissue and Skeletal Muscle Metabolism in Obese Patients With Type 2 Diabetes
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
- 21
- 试验地点
- 2
- 主要终点
- To explore whether vildagliptin augments insulin mediated inhibition of adipose tissue lipid mobilization following a mixed meal in patients with type 2 diabetes
研究概览
简要总结
Please note this study is not being conducted in the United States. The purpose of this study is to test the hypothesis that acute DPP-4 inhibition with vildagliptin improves fat and muscle metabolism in patients with type 2 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be able to complete a 3-week wash-out of current anti-diabetic medication
- •Cannot take any medications which may alter gastric motility except for cardiac medication at a stable dose
- •Must discontinue beta-blockers and lipid lowering drugs
- •Blood glucose criteria must be met
- •BMI in the range 30-35
排除标准
- •History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- •Need for insulin within 3 months or patients on thiazolidinediones
- •Patients taking a sulfonylurea or metformin who cannot safely discontinue medication for the duration of the study
- •Significant concomitant disease or complications of diabetes
- •Patients with any history of gastrointestinal surgery or positive gastrointestinal symptons
- •High tryglycerides as defined by the protocol
- •Smokers who cannot abstain from smoking during the treatment periods
结局指标
主要结局
To explore whether vildagliptin augments insulin mediated inhibition of adipose tissue lipid mobilization following a mixed meal in patients with type 2 diabetes
次要结局
- To measure the effects of vildagliptin on tissue carbohydrate metabolism (skeletal muscle)
研究者
研究点 (2)
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