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Completed

NCT Number: NCT03492580

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Janssen Investigative Site

Titusville, New Jersey, 08560, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Canagliflozin

Drug

No intervention or treatment assignment imposed by this study. Participants received canagliflozin as a part of routine clinical practice.

Empagliflozin

Drug

No intervention or treatment assignment imposed by this study. Participants received empagliflozin as a part of routine clinical practice.

Dapagliflozin

Drug

No intervention or treatment assignment imposed by this study. Participants received dapagliflozin as a part of routine clinical practice.

Dipeptidyl peptidase-4 (DPP-4) inhibitors

Drug

No intervention or treatment assignment imposed by this study. Participants received DPP-4 inhibitor as a part of routine clinical practice. DPP-4 inhibitors includes: alogliptin, linagliptin, saxagliptin, sitagliptin, vildagliptin.

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

Drug

No intervention or treatment assignment imposed by this study. Participants received GLP-1 agonist as a part of routine clinical practice. GLP-1 agonists includes: albiglutide, dulaglutide, exenatide, liraglutide, lixisenatide.

Anti-hyperglycemic Agents (AHA)

Drug

No intervention or treatment assignment imposed by this study. Participants received other selected AHA as a part of routine clinical practice. Other select AHAs includes: acarbose, bromocriptine, miglitol, nateglinide, repaglinide.

Thiazolidinediones (TZD)

Drug

No intervention or treatment assignment imposed by this study. Participants received TZD as a part of routine clinical practice. TZDs includes: pioglitazone, rosiglitazone, troglitazone.

Sulfonylureas (SU)

Drug

No intervention or treatment assignment imposed by this study. Participants received SU as a part of routine clinical practice. SUs includes: glipizide, glyburide, glimepiride, chlorpropamide, tolazamide, tolbutamide, acetohexamide

Insulin

Drug

No intervention or treatment assignment imposed by this study. Participants received Insulin as a part of routine clinical practice.

Primary outcomes

  1. Number of Hospitalizations for Heart Failure

    Time frame: Approximately 4-years

    Number of hospital admissions with a primary diagnosis of 'heart failure' will be reported.

  2. Number of Participants with Below Knee Lower Extremity Amputation Events

    Time frame: Approximately 4-years

    Number of participants with new below-knee lower extremity amputation procedures, excluding recent (within 30 day) revisions will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 10, 2018
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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