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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
1245.87.01013 Boehringer Ingelheim Investigational Site
New Haven, Connecticut, United States
1245.87.01004 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
1245.87.01002 Boehringer Ingelheim Investigational Site
Toledo, Ohio, United States
AUC0-inf
Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (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.
AUC0-tz
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).
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.
Cmax
Maximum measured concentration in plasma (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.
Tmax
Maximum measured concentration in plasma (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.
t1/2
Terminal half-life in plasma (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.
Change From Baseline in Urinary Glucose Excretion (UGE) Over 24 h After Study Drug Intake
Change from baseline in Urinary Glucose Excretion (UGE) over 24 h after study drug intake. For the changes from baseline in UGE on Day 1 (0 to 24 h postdose) , adjusted means per treatment group were to be calculated based on an ANCOVA including 'treatment' as a fixed effect and 'UGE at baseline' and 'FPG at baseline' as continuous covariates. Means presented are the adjusted means.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1245.87.01012 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
1245.87.01001 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania, United States
1245.87.33001 Boehringer Ingelheim Investigational Site
Lyon, France
1245.87.97202 Boehringer Ingelheim Investigational Site
Beersheba, Israel
1245.87.97203 Boehringer Ingelheim Investigational Site
Tel Litwinsky, Israel
1245.87.52001 Boehringer Ingelheim Investigational Site
Chihuahua City, Mexico
1245.87.27003 Boehringer Ingelheim Investigational Site
Bellville, South Africa
...and 1 more locations
Time frame: baseline and 24 hours
Change From Baseline in Fasting Plasma Glucose (FPG) at 24 h After Study Drug Intake
Change from baseline in Fasting Plasma Glucose (FPG) at 24h after study drug intake. For the change from baseline in FPG at 24 h postdose (in the morning of Day 2), adjusted means per treatment group were to be calculated based on an ANCOVA including 'treatment' as a fixed effect and 'FPG at baseline' as continuous covariate. Means presented are the adjusted means.
Time frame: baseline and 24 hours
Change From Baseline in 8-point Plasma Glucose Profile Over 24 h After Study Drug Intake
Change from baseline in 8-point plasma glucose profile over 24h after study drug intake (as defined by change from baseline in Mean Daily Glucose (MDG) calculated at Day 1). For the changes from baseline in MDG on Day 1, adjusted means per treatment group were to be calculated based on an ANCOVA including 'treatment' as fixed effect and 'MDG at baseline' as continuous covariate. Means presented are the adjusted means.
Time frame: baseline and 24 hours