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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
Lead sponsor
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 hospitalization•Major 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
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 endpointNumber of Participants with Below Knee Lower Extremity Amputation Events
Time frame:Approximately 4-years
Major amputation
event count, event
Heart failure
1 endpointNumber of Hospitalizations for Heart Failure
Time frame:Approximately 4-years
Heart-failure hospitalization
event count, event
SNOMED 84114007
Provenance
Sources
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.