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NCT03492580·Not applicable·OBSERVATIONAL

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

LiraglutideExenatideDulaglutideLixisenatideAlbiglutideOtherCompleted

Status

Completed

Phase

Not applicable

Enrollment

714,582

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Canagliflozin

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

DRUG

Empagliflozin

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

DRUG

Dapagliflozin

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

DRUG

Dipeptidyl Peptidase-4 (DPP-4) Inhibitors

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.

DRUG

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

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.

DRUG

Anti-hyperglycemic Agents (AHA)

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.

DRUG

Thiazolidinediones (TZD)

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

DRUG

Sulfonylureas (SU)

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

DRUG

Insulin

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

Timeline

From registration to results.

  1. First posted

    Apr 10, 2018

  2. Study start

    Feb 22, 2018

  3. Primary completion

    Apr 6, 2018

  4. Study completion

    Jun 25, 2018

  5. Results posted

    Not reported

  6. Registry updated

    Jun 25, 2025

Outcomes

What the study measures.

Primary outcomes

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.

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.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
Not reported
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Janssen Investigative Site

Titusville, New Jersey, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsLiraglutide trial dashboard →DatabaseLiraglutide database entry →ResearchLiraglutide research guide →TrialsExenatide trial dashboard →DatabaseExenatide database entry →ResearchExenatide research guide →TrialsDulaglutide trial dashboard →DatabaseDulaglutide database entry →ResearchDulaglutide research guide →TrialsLixisenatide trial dashboard →DatabaseLixisenatide database entry →ResearchLixisenatide research guide →TrialsAlbiglutide trial dashboard →DatabaseAlbiglutide database entry →ResearchAlbiglutide research guide →