Replication of the DECLARE Diabetes Trial in Healthcare Claims

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT04215523
Status
Completed

Conditions

  • Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Dapagliflozin dispensing claim for any dose is exposure
  • DPP-4 inhibitor — DRUG
    DPP4 inhibitor dispensing claim for any dose 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
Jul 8, 2019
Status verified
Jul 2023
Primary completion
Feb 18, 2021
Completion
Feb 18, 2021

Study Design

Enrollment
49,790 participants (actual)

Arms

  • Arm: Dapagliflozin
    Exposure group
  • Arm: DPP-4 inhibitor
    Reference group

Primary Outcome Measure

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-

Find similar trials in Boston, MA

By research site
Brigham & Women's Hospital· Boston, MA

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