Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin concentrations/levels in Pediatric Subjects with T2DM
Study identifier:CV181-153
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
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
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 1
Healthy volunteers
No
Study drug
Metformin immediate release (IR), Saxagliptin, Metformin IR, Saxagliptin/Metformin XR FDC, Metformin XR
Sex
All
Actual Enrollment
4
Study type
Interventional
Age
10 Years - 17 Years
Date
Study Start Date: 01 Sept 2012
Primary Completion Date: 01 Jun 2013
Study Completion Date: 01 Jun 2013
Study design
Allocation: N/A
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Other
Verification:
Verified 01 Jul 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Astra Zeneca
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC | Drug: Metformin immediate release (IR) Tablet, Oral, 1000 mg, twice daily, 1 day Other Name: Glucophage® IR Drug: Saxagliptin Tablet, Oral, 5 mg, single-dose, 1 day Drug: Metformin IR Tablet, Oral, 1000 mg, twice daily, 5 days Other Name: Glucophage® IR Drug: 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). Drug: Metformin XR Tablet, Oral, 500 mg, Single-dose of 4 tablets Other Name: Glucophage® XR |
Contacts
Contact
AstraZeneca Clinical Study Information Center Telephone no (US and Outside the US):
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Contact Backup
First line of the email MUST contain and Site #.
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-
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
