Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM
NCT ID: NCT01525225
Last Updated: 2015-06-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
4 participants
INTERVENTIONAL
2012-09-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC
Metformin immediate release (IR)
Tablet, Oral, 1000 mg, twice daily, 1 day
Saxagliptin
Tablet, Oral, 5 mg, single-dose, 1 day
Metformin IR
Tablet, Oral, 1000 mg, twice daily, 5 days
Saxagliptin/Metformin XR FDC
Tablet, Oral, 2.5 mg Saxagliptin/1000 mg Metformin extended release (XR), Single-dose of 2 tablets. Fixed dose combination (FDC).
Metformin XR
Tablet, Oral, 500 mg, Single-dose of 4 tablets
Interventions
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Metformin immediate release (IR)
Tablet, Oral, 1000 mg, twice daily, 1 day
Saxagliptin
Tablet, Oral, 5 mg, single-dose, 1 day
Metformin IR
Tablet, Oral, 1000 mg, twice daily, 5 days
Saxagliptin/Metformin XR FDC
Tablet, Oral, 2.5 mg Saxagliptin/1000 mg Metformin extended release (XR), Single-dose of 2 tablets. Fixed dose combination (FDC).
Metformin XR
Tablet, Oral, 500 mg, Single-dose of 4 tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male and female subjects ages 10-17
* Body weight ≥50 kg
* Glycosylated hemoglobin (HbA1c) 6.5 to 10%
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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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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Osborne Research Center
Little Rock, Arkansas, United States
Axis Clinical Trials
Los Angeles, California, United States
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States
The Children'S Mercy Hospital And Clinics
Kansas City, Missouri, United States
Promedica Toledo Children'S Hospital
Toledo, Ohio, United States
Promedica Toledo Childrens Hospital
Toledo, Ohio, United States
Childrens Hospital Of Pittsburgh Of Upmc
Pittsburgh, Pennsylvania, United States
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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CV181-153
Identifier Type: -
Identifier Source: org_study_id
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