Replication of the LEADER Diabetes Trial in Healthcare Claims

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT03936049
Status
Completed

Conditions

  • Diabetes

Eligibility Criteria

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

Interventions

  • Liraglutide — DRUG
    Liraglutide dispensing claim is used as the exposure group
  • DPP-4 inhibitor — DRUG
    DPP-4 inhibitor dispensing claim is used as the reference group

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
168,690 participants (actual)

Arms

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

Primary Outcome Measure

Relative hazard of composite outcome of Stroke, MI, and Mortality [ Time Frame: Through study completion (a median of 154-188 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham And Women's HospitalBostonMassachusetts02120-

Find similar trials in Boston, MA

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

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