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A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus

NCT03170518 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2025-04-25

Study results available
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Summary

The purpose of this study is to assess the effect of canagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 26 weeks of treatment, and to assess the overall safety and tolerability of canagliflozin.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Canagliflozin 100 mg

Canagliflozin 100 mg tablet will be administered orally (by mouth) once-daily.

DRUG

Canagliflozin 300 mg

Canagliflozin 300 mg tablet will be administered orally once-daily.

DRUG

Placebo

Matching placebo tablet will be administered orally once-daily.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

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
2017-07-21
Primary Completion
2023-09-20
Completion
2023-09-20
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • China
  • Greece
  • India
  • Malaysia
  • Mexico
  • Philippines
  • Poland
  • Russia

Study Locations

More Related Trials

Entities

Drugs

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 NCT03170518 on ClinicalTrials.gov