Emulation of the SOUL Diabetes Trial in Healthcare Claims

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06659718
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Oral semaglutide — DRUG
    New use of oral semaglutide dispensing claim is used as the exposure.
  • Sitagliptin — DRUG
    New initiation of sitagliptin dispensing claim is used as the reference.

Study Details

Investigators are building an empirical evidence base for real world data through large-scale emulation 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
Oct 24, 2024
Status verified
May 2025
Primary completion
Feb 13, 2025
Completion
Feb 13, 2025

Study Design

Enrollment
43,650 participants (actual)

Arms

  • Arm: Oral semaglutide
    Exposure group
  • Arm: Sitagliptin
    Reference group

Primary Outcome Measure

Major adverse cardiac event (MACE), including myocardial infarction, stroke and all cause death [ Time Frame: Through study completion (1 day after cohort entry date until the first of outcome or censoring) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02120-

Find similar trials in Boston, MA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Brigham and Women's Hospital· Boston, MA

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