EUCTR2013-005455-32-Outside-EU/EEA进行中（未招募）不适用
Open-Label, Multicenter, Multiple Oral Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents =10 to <18 years of age with Type 2 Diabetes Mellitus and Currently on a Stable Dose of Metformin.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 16
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
- •- Diagnosed with Type 2 Diabetes Mellitus
- •- Be on a stable regimen of metformin immediate release (IR) monotherapy of at least 1,000 mg/day for at least 8 weeks before screening
- •- Able to swallow whole tablets
- •- Absence of pancreatic autoimmunity
- •- Participants and their caregivers must agree to perform the fasting fingerstick glucose self-monitoring during the study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 16
- •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
- •- History of Type 1 diabetes mellitus
- •- History of maturity onset diabetes of the young (MODY) and any secondary form of diabetes
- •- Current clinically significant medical illness e.g., significant pulmonary disease, renal or hepatic insufficiency, uncontrolled thyroid disease
- •- Systolic or diastolic blood pressure outside the range considered normal for the participant sex, age and height
- •- For females, participants will be excluded if pregnant
研究者
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