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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Boehringer Ingelheim
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 29, 2014
Last verified: July 2014
  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-infinity (Area under the plasma concentration-time curve from time zero to infinite time) [ Time Frame: up to Day 3 ] [ Designated as safety issue: No ]
  • AUC0-tz (Area under the plasma concentration-time curve from time zero to the the time of the last quantifiable concentration) [ Time Frame: up to Day 3 ] [ Designated as safety issue: No ]
  • Cmax (Maximum observed plasma concentration) [ Time Frame: up to Day 3 ] [ Designated as safety issue: No ]
  • tmax (Time of maximum observed plasma concentration) [ Time Frame: up to Day 3 ] [ Designated as safety issue: No ]
  • t1/2 (Terminal half-life in plasma) [ Time Frame: up to Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in urinary glucose excretion [ Time Frame: over 24 hours after study drug intake ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (mg/dL) [ Time Frame: 24 hours after study drug intake ] [ Designated as safety issue: No ]
  • Change from baseline in 8-point plasma glucose profile [ Time Frame: over 24 hours after study drug intake ] [ Designated as safety issue: No ]

Estimated Enrollment: 27
Study Start Date: June 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Children and adolescents with type 2 diabetes mellitus
  • Insufficient glycaemic control (6.5% < HbA1c > 10.5%) despite diet and exercise and/or metformin
  • 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 screening
  • Current insulin therapy or having received insulin within 4 weeks before randomisation
  • 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

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Austria
1245.87.43001 Boehringer Ingelheim Investigational Site Not yet recruiting
Wien, Austria
Canada, Manitoba
1245.87.11002 Boehringer Ingelheim Investigational Site Not yet recruiting
Winnipeg, Manitoba, Canada
Canada, Quebec
1245.87.11001 Boehringer Ingelheim Investigational Site Not yet recruiting
Montreal, Quebec, Canada
France
1245.87.33001 Boehringer Ingelheim Investigational Site Recruiting
Lyon, France
Germany
1245.87.49001 Boehringer Ingelheim Investigational Site Not yet recruiting
Berlin, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

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
Last Updated: July 29, 2014
Health Authority: Austria: Austrian Medicines and Medical Devices Agency
Canada: Health Canada
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
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

ClinicalTrials.gov processed this record on July 29, 2014