NCT00351546已完成3 期
A Study to Assess the Effects of DPP-4 Inhibition on Insulin Sensitivity in 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
- 12
- 主要终点
- Effect on insulin sensitivity at 6 weeks
研究概览
简要总结
Type 2 diabetes results when the body does not produce enough insulin and/or is unable to properly use the insulin it makes (insulin resistance). This study was undertaken to assess the effects of vildagliptin on insulin sensitivity in people with type 2 diabetes.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes at least 3 months prior to screening
- •Blood glucose criteria must be met
- •On stable dose of metformin therapy
- •BMI less than or equal to 39
排除标准
- •Type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes
- •Treatment with thiazolidinediones or use of insulin within the previous 3 months
- •Significant illness within 2 weeks prior to dosing
- •High fasting triglycerides as defined by the protocol
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Effect on insulin sensitivity at 6 weeks
次要结局
- Lipolysis rate after 6 weeks of treatment
- Glucose disposal after 6 weeks of treatment
- Gluconeogenesis rate after 6 weeks of treatment
- Plasma free fatty acid concentration after 6 weeks of treatment
- Hepatic glucose production after 6 weeks of treatment
研究者
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