NCT00726505终止1 期
Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- The change in urinary glucose excretion dynamics
研究概览
简要总结
The purpose of this study is to evaluate the effects of dapagliflozin to promote glucose loss in urine in healthy subjects and subjects with type 2 diabetes mellitus
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects
- •Age 18 to 65 years
- •BMI 18 to 35 kg/m2
- •Healthy subjects and subjects with type 2 diabetes mellitus on 1 of the following therapies: diet, sulfonylurea, and/or metformin
- •No evidence of impaired renal function
排除标准
- •Unwilling or unable to use an acceptable method of birth control
- •Subjects with type 1 diabetes mellitus, heart disease, hepatic C or B
- •Exposure to insulin
- •Use of exclusionary concomitant medications
- •Evidence of significant kidney disease or any other significant medical or psychiatric disorder
研究组 & 干预措施
Group 1
Active Comparator
Subjects with T2DM - Dapagliflozin 5 mg
干预措施: Dapagliflozin (Drug)
Group 2
Active Comparator
Subjects with T2DM - Dapagliflozin 20 mg
干预措施: Dapagliflozin (Drug)
Group 3
Active Comparator
Healthy Subjects - Dapagliflozin 20 mg
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
The change in urinary glucose excretion dynamics
时间窗: after 7 days of treatment
次要结局
- Glucose effects on tubular markers(at one day)
- Differences in urinary glucose between healthy and diabetic subjects(at 7 days)
- Changes in liver glucose production(at one day)
研究者
研究点 (1)
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