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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

NCT01434186 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-04-18

Study results available
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Summary

To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination with Metformin in pediatric patients with type 2 diabetes

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)

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States
  • Belgium
  • Canada
  • India
  • Mexico
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01434186 on ClinicalTrials.gov