EUCTR2011-005225-40-Outside-EU/EEA进行中(未招募)不适用
A Randomized, Multi-Center, Parallel Group, Single-Dose, Pharmacokinetics and Pharmacodynamics Study of Dapagliflozin in Children and Adolescents Aged 10 to 17 Years with Type 2 Diabetes Mellitus - PK Study of Dapagliflozin in Pediatric Subjects with T2DM
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Clinical diagnosis of T2DM
- •Male and female subjects ages 10-17
- •HbA1c >6 to <10%
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 24
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Fasting plasma glucose (FPG) > 240 mg/dL at screening
- •Abnormal renal function
- •Active liver disease and/or significant abnormal liver function
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