Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM

Stopped early · Phase 1

Conditions studied: Type 2 Diabetes Mellitus

In brief

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 administration of Saxagliptin and Metformin XR fixed dose combination tablet and co-administration of Saxagliptin and Glucophage® (Metformin) IR tablets

Key facts

Study ID

NCT01525225

Run by

AstraZeneca

People needed

4

Starts

2012-09-01

Expected to finish

2013-06-01

Last updated by the study team

2015-06-22

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of T2DM
• Male and female subjects ages 10-17
• Body weight ≥50 kg
• Glycosylated hemoglobin (HbA1c) 6.5 to 10%

You may not qualify if…

• Fasting plasma glucose (FPG) > 240 mg/dL at screening
• Abnormal renal function
• Active liver disease and/or significant abnormal liver function

Where it is running

• 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

Full record on ClinicalTrials.gov

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