PK Study of Dapagliflozin in Pediatric Subjects With T2DM
NCT ID: NCT01525238
Last Updated: 2017-05-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
53 participants
INTERVENTIONAL
2012-07-01
2014-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Dapagliflozin 2.5 mg
Dapagliflozin
Tablet, Oral, 2.5 mg, Single-dose
Dapagliflozin 5 mg
Dapagliflozin
Tablet, Oral, 5 mg, Single-dose
Dapagliflozin 10 mg
Dapagliflozin
Tablet, Oral, 10 mg, Single-dose
Interventions
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Dapagliflozin
Tablet, Oral, 2.5 mg, Single-dose
Dapagliflozin
Tablet, Oral, 5 mg, Single-dose
Dapagliflozin
Tablet, Oral, 10 mg, Single-dose
Eligibility Criteria
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Inclusion Criteria
* Male and female subjects ages 10-17
* Glycosylated Hemoglobin A1c (HbA1c) ≥6 to 10%
* Body weight ≥30 kg
Exclusion Criteria
* Abnormal renal function
* Active liver disease and/or significant abnormal liver function
10 Years
17 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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The Children Hospital Of Alabama
Birmingham, Alabama, United States
Axis Clinical Trials
Los Angeles, California, United States
Nemours Childrens Hospital
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States
Lsuhsc-Shreveport
Shreveport, Louisiana, United States
Childrens Mercy Hospital
Kansas City, Missouri, United States
Women And Children'S Hopsital Of Buffalo
Buffalo, New York, United States
Promedica Toledo Children'S Hospital
Toledo, Ohio, United States
Mercy Children'S Hospital
Toledo, Ohio, United States
Children'S Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States
Children'S Hospital Of Pittsburgh Of Upmc
Pittsburgh, Pennsylvania, United States
Methodist Le Bonheur Hlthcare
Memphis, Tennessee, United States
Christus Santa Rosa Childrens Hospital
San Antonio, Texas, United States
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Monterrey, Nuevo León, Mexico
Local Institution
Veracruz, , Mexico
Countries
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Other Identifiers
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2011-005225-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MB102-091
Identifier Type: -
Identifier Source: org_study_id
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