PK Study of Dapagliflozin in Pediatric Subjects With T2DM

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 24, 2014
Last verified: September 2014
  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: February 2015
Primary Completion Date: December 2013 (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
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: NCT01525238

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
United States, Alabama
The Children Hospital Of Alabama Active, not recruiting
Birmingham, Alabama, United States, 35233
United States, California
Local Institution Not yet recruiting
Los Angeles, California, United States, 90015
Contact: Site 0015         
Axis Clinical Trials Completed
Los Angeles, California, United States, 90036
United States, Florida
Nemours Childrens Hospital Completed
Orlando, Florida, United States, 32827
United States, Georgia
Emory University Active, not recruiting
Atlanta, Georgia, United States, 30322
United States, Kentucky
Kosair Charities Pediatric Clinical Research Unit Completed
Louisville, Kentucky, United States, 40202
United States, Louisiana
Lsuhsc-Shreveport Active, not recruiting
Shreveport, Louisiana, United States, 71103
United States, Missouri
Childrens Mercy Hospital Completed
Kansas City, Missouri, United States, 64108
United States, New York
Women And Children'S Hopsital Of Buffalo Completed
Buffalo, New York, United States, 14222
United States, Ohio
Promedica Toledo Children'S Hospital Completed
Toledo, Ohio, United States, 43606
Mercy Children'S Hospital Completed
Toledo, Ohio, United States, 43608
United States, Pennsylvania
Children'S Hospital Of Philadelphia Completed
Philadelphia, Pennsylvania, United States, 19104
Children'S Hospital Of Pittsburgh Of Upmc Completed
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Methodist Le Bonheur Hlthcare Active, not recruiting
Memphis, Tennessee, United States, 38103
United States, Texas
Christus Santa Rosa Childrens Hospital Completed
San Antonio, Texas, United States, 78207
Mexico
Local Institution Recruiting
Guadalajara, Jalisco, Mexico, 44150
Contact: Site 0018         
Local Institution Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Contact: Site 0017         
Local Institution 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: September 24, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 22, 2014