EUCTR2013-002304-14-Outside-EU/EEA进行中（未招募）不适用
An open-label, randomised, multicentre, single-dose, parallel group trial to evaluate pharmacokinetics and pharmacodynamics of empagliflozin in children and adolescents from 10 to less than 18 years of age with type 2 diabetes mellitus
Boehringer Ingelheim Pharmaceuticals (Pty) Ltd.0 个研究点目标入组 60 人开始时间: 2014年5月6日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •- Children and adolescents with type 2 diabetes mellitus
- •- Insufficient glycaemic control (6.5% < HbA1c > 10.5%) despite diet and exercise and/or metformin
- •- Negative for Islet Cell Antigen and Glutamic Acid Decarboxylase autoantibodies and fasting C-peptide levels >= 0.85 ng/ml
- •- BMI > 50th percentile for age and sex
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 27
- •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
- •- Uncontrolled hyperglycaemia with a glucose level > 240 mg/dl (> 13.3 mmol/l)
- •- History of acute metabolic decompensation such as diabetic ketoacidosis within 3 months before screening
- •- Current insulin therapy or having received insulin within 4 weeks before randomisation
- •- Treatment with weight reduction medications within 4 weeks before randomisation
研究者
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