← Trials/Trial dossier/NCT03492580

Completed

A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease

Comparison of Canagliflozin vs. Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Patients With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease

Assets

Albiglutide / Dulaglutide / Exenatide / GLP-1 / incretin class catch-all / Liraglutide / Lixisenatide

Listed sites

1

Recruiting sites

Enrollment

714,582

actual

Study population

Cardiovascular disease, Type 2 diabetes

Key I/E criterion

Established CVD

Primary endpoints

Heart-failure hospitalizationMajor amputation

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03492580
Org study IDCR108464
Secondary IDRRA-20250Janssen Research & Development, LLC

Timeline

Milestones

Study start2018-02-22actual
Primary completion2018-04-06actual
Study first posted2018-04-10actual
Study completion2018-06-25actual
Last update posted2025-06-25actual

Assets

Investigational agents

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Participants diagnosed with type 2 diabetes mellitus (T2DM) and established cardiovascular (CV) disease over a 4-year period 1 April 2013 and 15 May 2017 will be observed.

Inclusion criteria

First exposure to the particular drug(s) in database (index date)
Exposure start is between 1 April 2013 and 15 May 2017
At least 365 days of continuous observation time prior to index
At least 1 condition occurrence of 'Type II diabetes' any time in the prior continuous observation time (which is at least 365 days long) before or on the index date (first exposure to the particular drug(s) in database)

For cohort with 'established cardiovascular disease - At least 1 occurrence of 'conditions indicating established cardiovascular disease' on or any time in the prior continuous observation time (which is at least 365 days long) prior to the index date

Exclusion criteria

- Participants with type 1 diabetes or secondary diabetes prior to or on the index date of exposure were excluded from the study

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiovascular outcomes
1
Heart failure
1

Cardiovascular outcomes

1 endpoint
Primary/protocol endpoint

Number of Participants with Below Knee Lower Extremity Amputation Events

Time frame:Approximately 4-years

Major amputation

event count, event

Heart failure

1 endpoint
Primary/protocol endpoint

Number of Hospitalizations for Heart Failure

Time frame:Approximately 4-years

Heart-failure hospitalization

event count, event

SNOMED 84114007

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.