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 Pharma GmbH & Co. KG0 个研究点目标入组 60 人开始时间: 2014年5月5日最近更新: 2015年9月7日

适应症

试验速览

暂无简介。

•- Children and adolescents with type 2 diabetes mellitus aged 10 to less than 18 years at the time of randomisation and during study participation
•- Insufficient glycaemic control (HbA1c = 10.5%) despite diet and exercise and/or stable metformin and/or stable basal insulin
•- 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

•- 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 with the exception of acute de-compensation at the time of type 2 diabetes diagnosis
•- Treatment with weight reduction medications within 4 weeks before randomisation
•- Current short-acting insulin or having received short-acting inulin for more than 3 days within 12 weeks prior to randomisation
•- Patients who are legally institutionalised

发起方