Status:
TERMINATED
Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
10-17 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics of Saxagliptin, 5-hydroxy Saxagliptin, and Metformin in pediatric subjects with Type 2 diabetes mellitus (T2DM) following oral administrat...
Detailed Description
The primary purpose is to assess the pharmacokinetics of Saxagliptin, 5-hydroxy Saxagliptin, and Metformin in pediatric subjects aged 10 to 17 years with T2DM following oral administration of Saxaglip...
Eligibility Criteria
Inclusion
- Clinical diagnosis of T2DM
- Male and female subjects ages 10-17
- Body weight ≥50 kg
- Glycosylated hemoglobin (HbA1c) 6.5 to 10%
Exclusion
- Fasting plasma glucose (FPG) \> 240 mg/dL at screening
- Abnormal renal function
- Active liver disease and/or significant abnormal liver function
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01525225
Start Date
September 1 2012
End Date
June 1 2013
Last Update
June 22 2015
Active Locations (7)
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1
Osborne Research Center
Little Rock, Arkansas, United States, 72201
2
Axis Clinical Trials
Los Angeles, California, United States, 90036
3
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States, 40202
4
The Children'S Mercy Hospital And Clinics
Kansas City, Missouri, United States, 64108