PK Study of Dapagliflozin in Pediatric Subjects With T2DM

This study is currently recruiting participants.
Verified December 2013 by Bristol-Myers Squibb
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01525238
First received: January 31, 2012
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin in pediatric subjects with type 2 diabetes mellitus (T2DM)


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Dapagliflozin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Randomized, Multi-Center, Parallel Group, Single-Dose, Pharmacokinetics and Pharmacodynamics Study of Dapagliflozin in Children and Adolescents Aged 10 to 17 Years With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Maximum observed plasma concentration (Cmax) of Dapagliflozin derived from plasma concentration versus time [ Time Frame: 11 time points up to Day 3 ] [ Designated as safety issue: No ]
  • Time of maximum observed plasma concentration (Tmax) of Dapagliflozin derived from plasma concentration versus time [ Time Frame: 11 time points up to Day 3 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Dapagliflozin derived from plasma concentration versus time [ Time Frame: 11 time points up to Day 3 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of Dapagliflozin derived from plasma concentration versus time [ Time Frame: 11 time points up to Day 3 ] [ Designated as safety issue: No ]
  • Plasma half-life (T-HALF) of Dapagliflozin derived from plasma concentration versus time [ Time Frame: 11 time points up to Day 3 ] [ Designated as safety issue: No ]
  • Apparent clearance after extravascular administration (CL/F) of Dapagliflozin derived from plasma concentration versus time [ Time Frame: 11 time points up to Day 3 ] [ Designated as safety issue: No ]
  • Apparent volume of distribution at terminal phase after extravascular administration (Vz/F) of Dapagliflozin derived from plasma concentration versus time [ Time Frame: 11 time points up to Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: based on medical review of adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs) and clinical laboratory tests [ Time Frame: Up to Day 3 ] [ Designated as safety issue: Yes ]
  • Maximum observed plasma concentration (Cmax) of Dapagliflozin 3-O-Glucuronide [ Time Frame: 11 time points up to Day 3 ] [ Designated as safety issue: No ]
  • Time of maximum observed plasma concentration (Tmax) of Dapagliflozin 3-O-Glucuronide [ Time Frame: 11 time points up to Day 3 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Dapagliflozin 3-O-Glucuronide [ Time Frame: 11 time points up to Day 3 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of Dapagliflozin 3-O-Glucuronide [ Time Frame: 11 time points up to Day 3 ] [ Designated as safety issue: No ]
  • Plasma half-life (T-HALF) of Dapagliflozin 3-O-Glucuronide [ Time Frame: 11 time points up to Day 3 ] [ Designated as safety issue: No ]
  • Fasting plasma glucose concentration [ Time Frame: At pre-dose on Day 1 and Day 2 after an 8-hr fasting ] [ Designated as safety issue: No ]
  • Urinary glucose amounts [ Time Frame: First 24 h after Dapagliflozin administration ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: July 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dapagliflozin 2.5 mg Drug: Dapagliflozin
Tablet, Oral, 2.5 mg, Single-dose
Experimental: Dapagliflozin 5 mg Drug: Dapagliflozin
Tablet, Oral, 5 mg, Single-dose
Experimental: Dapagliflozin 10 mg Drug: Dapagliflozin
Tablet, Oral, 10 mg, Single-dose

Detailed Description:

Primary purpose: The primary purpose is to assess the pharmacokinetics of a single dose of Dapagliflozin in the range of 2.5 to 10 mg in pediatric subjects aged 10 to 17 years with T2DM

  Eligibility

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

Inclusion Criteria:

  • Clinical diagnosis of T2DM
  • Male and female subjects ages 10-17
  • Glycosylated Hemoglobin A1c (HbA1c) >6 to <10%

Exclusion Criteria:

  • Fasting plasma glucose (FPG) >240 mg/dL at screening
  • Abnormal renal function
  • Active liver disease and/or significant abnormal liver function
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525238

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations
United States, Alabama
The Children Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233-1711
Contact: Mary Scott, Site 0013         
United States, California
Axis Clinical Trials Recruiting
Los Angeles, California, United States, 90036
Contact: Lydie Hazan, Site 0009         
Local Institution Not yet recruiting
Los Angeles, California, United States, 90015
Contact: Site 0015         
United States, Florida
Nemours Childrens Hospital Recruiting
Orlando, Florida, United States, 32827
Contact: Miles Yu, Site 0011         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Andrew Muir, Site 0010         
United States, Kentucky
Kosair Charities Pediatric Clinical Research Unit Recruiting
Louisville, Kentucky, United States, 40202
Contact: Kupper Wintergerst, Site 0007         
United States, Missouri
Childrens Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Mark Clements, Site 0002         
United States, New York
Women and Children's Hopsital of Buffalo Recruiting
Buffalo, New York, United States, 14222
Contact: Lucy Mastrandrea, Site 014    716-878-7268      
United States, Ohio
Mercy Children's Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Jeffrey L Blumer, Site 0003         
ProMedica Toledo Childrens Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Jeffrey L Blumer, Site 0005         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Steven Willi, Site 001         
Children's Hopsital Of Pittsburgh Of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Kara Hughan, Site 0008         
United States, Tennessee
Methodist Le Bonheur Hlthcare Recruiting
Memphis, Tennessee, United States, 38103-2800
Contact: Sunil Sinha, Site 0012         
United States, Texas
University Of Texas Health Science Center At San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Jane Lynch, Site 0004         
Mexico
Local Institution Not yet recruiting
Guadalajara, Jalisco, Mexico, 44150
Contact: Site 0018         
Local Institution Not yet recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Contact: Site 0017         
Local Institution Not yet recruiting
Veracruz, Mexico, 91910
Contact: Site 0016         
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01525238     History of Changes
Other Study ID Numbers: MB102-091, 2011-005225-40
Study First Received: January 31, 2012
Last Updated: December 17, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014