Emulation of the SUSTAIN6 Diabetes Trial Using Healthcare Claims

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06659744
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • New use of semaglutide injection — DRUG
    New use of semaglutide injection dispensing claim is used as the exposure.
  • New initiation of 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
Aug 2025
Primary completion
Mar 6, 2025
Completion
Mar 6, 2025

Study Design

Enrollment
158,310 participants (actual)

Arms

  • Arm: New use of semaglutide injection
    Exposure group
  • Arm: New initiation of 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-

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