A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

PHASE3CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Placebo matching with Saxagliptin

Tablet, Oral, 0.0 mg, Daily, Day 1 through week 52

DRUG

Metformin IR

Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52

DRUG

Metformin XR

Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52

DRUG

Saxagliptin

Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight)

Trial Locations (16)

Unknown

Research Site, Los Angeles

Research Site, Tallahassee

Research Site, Dearborn

Research Site, Saint Paul

Research Site, Mineola

Research Site, Cleveland

Research Site, Memphis

Research Site, Namur

Research Site, Calgary

Research Site, Bangalore

Research Site, Aguascalientes

Research Site, Meridas

Research Site, Monterrey

Research Site, Veracruz

Research Site, Taichung

Research Site, Leicester

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

AstraZeneca

INDUSTRY