Phase 1
Completed N=27
Pharmacokinetic Single Dose Trial of Empagliflozin in Children and Adolescents With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02121483 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcomePrimary: AUC0-inf — 1150; 1430; 5060 nmol*h/L
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC0-inf |
1150; 1430; 5060 | — |
| PRIMARY AUC0-tz |
1110; 1400; 4980 | — |
| PRIMARY Cmax |
159; 188; 602 | — |
| PRIMARY Tmax |
1.50; 1.25; 1.78 | — |
| PRIMARY t1/2 |
6.92; 7.35; 7.80 | — |
| SECONDARY Change From Baseline in Urinary Glucose Excretion (UGE) Over 24 h After Study Drug Intake |
53.1; 73.0; 87.4 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at 24 h After Study Drug Intake |
-15.5; -16.6; -20.4 | — |
| SECONDARY Change From Baseline in 8-point Plasma Glucose Profile Over 24 h After Study Drug Intake |
-12.9; -6.5; -13.2 | — |
Eligibility Criteria
Inclusion criteria
- Children and adolescents with type 2 diabetes mellitus
- Insufficient glycaemic control (HbA1c = 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
Data sourced from ClinicalTrials.gov (NCT02121483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.