Replication of the CANVAS Diabetes Trial in Healthcare Claims

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT03936010
Status
Completed

Conditions

  • Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin — DRUG
    Canagliflozin dispensing claim is exposure
  • DPP-4 inhibitor — DRUG
    DPP4 inhibitor dispensing claim is reference

Study Details

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Key Dates

Start date
Sep 22, 2017
Status verified
Jul 2023
Primary completion
Feb 18, 2021
Completion
Feb 18, 2021

Study Design

Enrollment
152,202 participants (actual)

Arms

  • Arm: DPP4i
    Reference group
  • Arm: Canagliflozin
    Exposure group

Primary Outcome Measure

Relative hazard of composite outcome of Stroke, MI, and Mortality [ Time Frame: Through study completion (a median of 120-140 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham & Women's HospitalBostonMassachusetts02120-

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