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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: empagliflozin high dose; Drug: empagliflozin medium dose; Drug: empagliflozin low dose

• 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

Study Timeline

• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-23
• Study Start: 2014-06
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-07
• Results First Submitted: 2016-07-28
• Results First Submitted QC: 2016-07-28
• Last Update Submitted: 2016-07-28
• Results First Posted: 2016-09-19
• Last Update Posted: 2016-09-19

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

Group	Intervention	Description
empagliflozin high dose	empagliflozin high dose	Patient to receive a high dose of empagliflozin
empagliflozin medium dose	empagliflozin medium dose	Patient to receive a medium dose of empagliflozin
empagliflozin low dose	empagliflozin low dose	Patient to receive a low dose of empagliflozin

Primary Outcome Measures

Name	Time	Method
t1/2	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	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	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	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	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 Outcome Measures

Name	Time	Method
Change From Baseline in Urinary Glucose Excretion (UGE) Over 24 h After Study Drug Intake	baseline 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 Intake	baseline 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 Intake	baseline 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