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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:
ClinicalTrials.gov Identifier:
NCT02121483
First Posted: April 23, 2014
Last Update Posted: September 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
  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
Intervention Model: Parallel Assignment
Masking: None (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. ]
    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. ]
    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).

  • 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).

  • 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).


Secondary Outcome Measures:
  • Change From Baseline in Urinary Glucose Excretion (UGE) Over 24 h After Study Drug Intake [ Time Frame: 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 Fasting Plasma Glucose (FPG) at 24 h After Study Drug Intake [ Time Frame: 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.


  • Change From Baseline in 8-point Plasma Glucose Profile Over 24 h After Study Drug Intake [ Time Frame: 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.



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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( EudraCT Number: EudraCT )
First Submitted: April 22, 2014
First Posted: April 23, 2014
Results First Submitted: July 28, 2016
Results First Posted: September 19, 2016
Last Update Posted: September 19, 2016
Last Verified: July 2016

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