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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02121483
First received: April 22, 2014
Last updated: July 28, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: empagliflozin medium dose
Drug: empagliflozin high dose
Drug: empagliflozin low dose
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).

  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Maximum measured concentration in plasma (Cmax).

  • 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. ] [ Designated as safety issue: No ]
    Maximum measured concentration in plasma (tmax).

  • 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. ] [ Designated as safety issue: No ]
    Terminal half-life in plasma (t1/2).


Secondary Outcome Measures:
  • Change From Baseline in Urinary Glucose Excretion (UGE) Over 24 h After Study Drug Intake [ Time Frame: baseline and 24 hours ] [ Designated as safety issue: No ]

    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 Fasting Plasma Glucose (FPG) at 24 h After Study Drug Intake [ Time Frame: baseline and 24 hours ] [ Designated as safety issue: No ]

    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.


  • Change From Baseline in 8-point Plasma Glucose Profile Over 24 h After Study Drug Intake [ Time Frame: baseline and 24 hours ] [ Designated as safety issue: No ]

    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.



Enrollment: 27
Study Start Date: June 2014
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: empagliflozin high dose
Patient to receive a high dose of empagliflozin
Drug: empagliflozin high dose
Experimental: empagliflozin medium dose
Patient to receive a medium dose of empagliflozin
Drug: empagliflozin medium dose
Experimental: empagliflozin low dose
Patient to receive a low dose of empagliflozin
Drug: empagliflozin low dose

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Children and adolescents with type 2 diabetes mellitus
  • Insufficient glycaemic control (HbA1c <=10.5%) despite diet and exercise and/or metformin and/or stable basal or MDI insulin
  • Negative for Islet Cell Antigen and Glutamic Acid Decarboxylase autoantibodies and fasting C-peptide levels >= 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02121483

Locations
United States, Connecticut
1245.87.01013 Boehringer Ingelheim Investigational Site
New Haven, Connecticut, United States
United States, Massachusetts
1245.87.01004 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
United States, Ohio
1245.87.01002 Boehringer Ingelheim Investigational Site
Toledo, Ohio, United States
United States, Pennsylvania
1245.87.01012 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
1245.87.01001 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania, United States
France
1245.87.33001 Boehringer Ingelheim Investigational Site
Lyon, France
Israel
1245.87.97202 Boehringer Ingelheim Investigational Site
Beer Sheva, Israel
1245.87.97203 Boehringer Ingelheim Investigational Site
Tel Hashomer, Israel
Mexico
1245.87.52001 Boehringer Ingelheim Investigational Site
Chihuahua, Mexico
South Africa
1245.87.27003 Boehringer Ingelheim Investigational Site
Bellville, South Africa
1245.87.27002 Boehringer Ingelheim Investigational Site
Pretoria, South Africa
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02121483     History of Changes
Other Study ID Numbers: 1245.87  2013-002304-14 
Study First Received: April 22, 2014
Results First Received: July 28, 2016
Last Updated: July 28, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Israel: Israeli Health Ministry Pharmaceutical Administration
Mexico: Federal Commission for Sanitary Risks Protection
South Africa: Medicines Control Council
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Empagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2016