NCT00238472已完成4 期
A Pilot Study to Evaluate the Effects of Nateglinide vs. Glibenclamide on Renal Hemodynamics and Albumin Excretion
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Change from baseline in postprandial glomerular filtration rate at 12 weeks
研究概览
简要总结
This study is not being conducted in the United States. The purpose of the study is to evaluate the effects of nateglinide compared to glibenclamide on renal hemodynamics and albumin excretion.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes diagnosed at least 1 year before inclusion
- •Blood glucose criteria must be met
- •Microalbuminuria criteria must be met
排除标准
- •Pregnant or nursing females or females of childbearing potential not using a medically approved birth control method
- •Blood glucose criteria outside the specified range
- •Microalbuminuria criteria outside the specified range
- •Serious cardiovascular events within the past 6 months
- •Other protocol-defined exclusion criteria may apply
结局指标
主要结局
Change from baseline in postprandial glomerular filtration rate at 12 weeks
次要结局
- Change from baseline in fasting morning glomerular filtration rate at 12 weeks
- Change from baseline in postprandial renal plasma flow at 12 weeks
- Change from baseline in fasting morning renal plasma flow at 12 weeks
- Change from baseline in adjusted 2-hour postprandial glucose at 12 weeks
- Change in insulin AUC (0-240 minutes) at 12 weeks
研究者
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