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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 | Clinical Trials | Clareo Health

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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

NCT03492580•Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The primary purpose of study is to estimate the incidence and comparative effect on health outcomes: 1) hospitalization for heart failure, 2) below knee lower extremity amputation. The date of first exposure to the particular drug(s) in the database, where the exposure start is between 1-April-2013 to 15-May-2017 and outcome data for these participants will be analyzed and reported in this study.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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

Locations (1)

Janssen Investigative Site

Titusville, New Jersey, United States

Key Dates

Start Date

February 22, 2018

Primary Completion Date

April 6, 2018

Completion Date

June 25, 2018

Last Updated

June 25, 2025

Enrollment

714,582

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2Cardiovascular Diseases

Interventions

Canagliflozin

DRUG

Empagliflozin

DRUG

Dapagliflozin

DRUG

Dipeptidyl Peptidase-4 (DPP-4) Inhibitors

DRUG

Glucagon-like Peptide-1 (GLP-1) Agonist

DRUG

Anti-hyperglycemic Agents (AHA)

DRUG

Thiazolidinediones (TZD)

DRUG

Sulfonylureas (SU)

DRUG

Insulin

DRUG

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Cardiovascular Diseases

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Cardiovascular DiseasesCardiac Rehabilitation

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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