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
Overview
- Phase
- Phase 1
- Intervention
- empagliflozin medium dose
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 27
- Locations
- 11
- Primary Endpoint
- t1/2
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
empagliflozin medium dose
Patient to receive a medium dose of empagliflozin
Intervention: empagliflozin medium dose
empagliflozin low dose
Patient to receive a low dose of empagliflozin
Intervention: empagliflozin low dose
empagliflozin high dose
Patient to receive a high dose of empagliflozin
Intervention: empagliflozin high dose
Outcomes
Primary Outcomes
t1/2
Time Frame: Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.
Terminal half-life in plasma (t1/2).
AUC0-tz
Time Frame: Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz).
Cmax
Time Frame: Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.
Maximum measured concentration in plasma (Cmax).
AUC0-inf
Time Frame: Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.
Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).
Tmax
Time Frame: Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.
Maximum measured concentration in plasma (tmax).
Secondary Outcomes
- Change From Baseline in Urinary Glucose Excretion (UGE) Over 24 h After Study Drug Intake(baseline and 24 hours)
- Change From Baseline in 8-point Plasma Glucose Profile Over 24 h After Study Drug Intake(baseline and 24 hours)
- Change From Baseline in Fasting Plasma Glucose (FPG) at 24 h After Study Drug Intake(baseline and 24 hours)