MedTrace Logo

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

NCT01204775 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-04-18

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability, of Saxagliptin in pediatric patients with type 2 diabetes.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States
  • Russia
  • South Africa
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01204775 on ClinicalTrials.gov