NCT00351585已完成3 期
A Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Effects of Vildagliptin on the Maximum Insulin Secretion in Patients With Type 2 Diabetes Mellitus
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
- 39
- 主要终点
- Change from baseline in maximal insulin secretory capacity at 12 weeks
研究概览
简要总结
Type 2 diabetes results when the body does not produce enough insulin to regulate blood sugar. This study is designed to measure the effect of vildagliptin on the maximum insulin secretion by the pancreas.
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 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 for at least 6 months
- •Patients whose diabetes is controlled by diet and exercise only or patients taking metformin
- •BMI in the range 22-45
- •Blood glucose criteria must be met
排除标准
- •Pregnancy or lactation
- •Type 1 diabetes or diabetes resulting from pancreatic injury
- •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 in maximal insulin secretory capacity at 12 weeks
Durability of this effect after a 2-week washout
次要结局
- Change from baseline in beta-cell sensitivity to glucose at 12 weeks
- Durability of this effect after a 2-week washout
- Chance from baseline in glucagon secretion at 12 weeks
研究者
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