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A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus

NCT01989754 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5813

Last updated 2018-12-11

Study results available
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Summary

The purpose of this study is to assess the effect of canagliflozin compared to placebo on progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard care but with inadequate glycemic control and at elevated risk of cardiovascular events.

Conditions

Interventions

DRUG

Placebo

One placebo capsule taken orally (by mouth) once daily for 156 weeks

DRUG

Canagliflozin, 100 mg

One 100 mg capsule taken orally (by mouth) once daily

DRUG

Canagliflozin, 300 mg

One 300 mg capsule taken orally (by mouth) once daily

Sponsors & Collaborators

  • The George Institute for Global Health, Australia

    collaborator OTHER

  • 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
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-16
Primary Completion
2017-02-23
Completion
2017-02-23

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Malaysia
  • Mexico
  • Netherlands
  • New Zealand
  • Poland
  • Puerto Rico
  • Russia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01989754 on ClinicalTrials.gov