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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01525225 |
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Date of registration:
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31/01/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM
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Scientific title:
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Evaluation of the Pharmacokinetics of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin in Children and Adolescents Aged 10 to 17 Years With Type 2 Diabetes Mellitus Following Oral Administration of Saxagliptin and Metformin XR Fixed Dose Combination Tablet and Co-Administration of Saxagliptin and Glucophage® (Metformin) IR Tablets |
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Date of first enrolment:
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September 2012 |
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Target sample size:
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4 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01525225 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Bristol-Myers Squibb |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bristol-Myers Squibb |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical diagnosis of T2DM
- Male and female subjects ages 10-17
- Body weight =50 kg
- Glycosylated hemoglobin (HbA1c) 6.5 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
Age minimum:
10 Years
Age maximum:
17 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes Mellitus
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Intervention(s)
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Drug: Metformin XR
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Drug: Saxagliptin/Metformin XR FDC
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Drug: Metformin IR
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Drug: Saxagliptin
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Drug: Metformin immediate release (IR)
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Primary Outcome(s)
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Number of Participants With Adverse Events (AEs) , Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Death
[Time Frame: Day 1 up to Day 8, plus 30 days]
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Secondary Outcome(s)
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Number of Participants With Marked Chemistry or Hematology Laboratory Abnormalities
[Time Frame: Day 1 to Day 8]
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Secondary ID(s)
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CV181-153
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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