Pharmacokinetic Single Dose Trial of Empagliflozin in Children and Adolescents With Type 2 Diabetes Mellitus
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 10 - 17 |
| Updated: | 4/21/2016 |
| Start Date: | June 2014 |
| End Date: | February 2016 |
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
The aim of the study is to generate pharmacokinetic and pharmacodynamic data to identify the
safe-effective dose of empagliflozin in children and adolescents aged 10 to less than 18
years with type 2 diabetes mellitus.
safe-effective dose of empagliflozin in children and adolescents aged 10 to less than 18
years with type 2 diabetes mellitus.
Inclusion criteria:
- Children and adolescents with type 2 diabetes mellitus
- Insufficient glycaemic control (HbA1c <=10.5%) despite diet and exercise and/or
metformin and/or stable basal or MDI 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
Exclusion criteria:
- 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 the screening visit 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
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