NCT01204775 - Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions

Type 2 Diabetes

Interventions

DRUG

Saxagliptin

Tablets, Oral, 2.5 mg or 5.0 mg (according to body weight category), Once Daily, 1-52 weeks

DRUG

Placebo (Saxagliptin)

Tablets, Oral, Once daily, 1-16 weeks

DRUG

Metformin IR

Tablets, Oral, 500 mg, Once Daily, 17-52 weeks

DRUG

Placebo (Metformin)

Tablets, Oral, Once daily, 1-16 weeks

DRUG

Metformin (Active Rescue)

Tablets, Oral, 500 mg, Titrated as needed, 2-52 weeks

Trial Locations (16)

Research Site, Los Angeles

Research Site, San Diego

Research Site, Hollywood

Research Site, Tallahassee

Research Site, Tampa

Research Site, Dearborn

Research Site, Buffalo

Research Site, Memphis

Research Site, Richmond

Research Site, Moscow

Research Site, Novosibirsk

Research Site, Saint Petersburg

Research Site, Cape Town

Research Site, Pretoria

Research Site, Taichung

Research Site, Taipei