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Pharmacokinetic Single Dose Trial of Empagliflozin in Children and Adolescents With Type 2 Diabetes Mellitus

Phase 1
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Registration Number
NCT02121483
Lead Sponsor
Boehringer Ingelheim
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
27
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
empagliflozin high doseempagliflozin high dosePatient to receive a high dose of empagliflozin
empagliflozin medium doseempagliflozin medium dosePatient to receive a medium dose of empagliflozin
empagliflozin low doseempagliflozin low dosePatient to receive a low dose of empagliflozin
Primary Outcome Measures
NameTimeMethod
t1/2Before 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-tzBefore 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).

CmaxBefore 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-infBefore 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).

TmaxBefore 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 Outcome Measures
NameTimeMethod
Change From Baseline in Urinary Glucose Excretion (UGE) Over 24 h After Study Drug Intakebaseline and 24 hours

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.

Change From Baseline in 8-point Plasma Glucose Profile Over 24 h After Study Drug Intakebaseline and 24 hours

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.

Change From Baseline in Fasting Plasma Glucose (FPG) at 24 h After Study Drug Intakebaseline and 24 hours

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.

Trial Locations

Locations (11)

1245.87.27003 Boehringer Ingelheim Investigational Site

🇿🇦

Bellville, South Africa

1245.87.27002 Boehringer Ingelheim Investigational Site

🇿🇦

Pretoria, South Africa

1245.87.52001 Boehringer Ingelheim Investigational Site

🇲🇽

Chihuahua, Mexico

1245.87.01002 Boehringer Ingelheim Investigational Site

🇺🇸

Toledo, Ohio, United States

1245.87.01012 Boehringer Ingelheim Investigational Site

🇺🇸

Philadelphia, Pennsylvania, United States

1245.87.97202 Boehringer Ingelheim Investigational Site

🇮🇱

Beer Sheva, Israel

1245.87.33001 Boehringer Ingelheim Investigational Site

🇫🇷

Lyon, France

1245.87.01004 Boehringer Ingelheim Investigational Site

🇺🇸

Boston, Massachusetts, United States

1245.87.01013 Boehringer Ingelheim Investigational Site

🇺🇸

New Haven, Connecticut, United States

1245.87.01001 Boehringer Ingelheim Investigational Site

🇺🇸

Pittsburgh, Pennsylvania, United States

1245.87.97203 Boehringer Ingelheim Investigational Site

🇮🇱

Tel Hashomer, Israel

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