NCT01525225 - Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions

Type 2 Diabetes Mellitus

Interventions

DRUG

Metformin immediate release (IR)

Tablet, Oral, 1000 mg, twice daily, 1 day

DRUG

Saxagliptin

Tablet, Oral, 5 mg, single-dose, 1 day

DRUG

Metformin IR

Tablet, Oral, 1000 mg, twice daily, 5 days

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

Trial Locations (7)

Childrens Hospital Of Pittsburgh Of Upmc, Pittsburgh

Kosair Charities Pediatric Clinical Research Unit, Louisville

Promedica Toledo Children'S Hospital, Toledo

Promedica Toledo Childrens Hospital, Toledo

The Children'S Mercy Hospital And Clinics, Kansas City

Osborne Research Center, Little Rock

Axis Clinical Trials, Los Angeles