Emulating the PIONEER6 Diabetes Trial Using Healthcare Claims

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06659679
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • New use of oral semaglutide — DRUG
    New use of oral semaglutide dispensing claim is used as the exposure.
  • New initiation of sitagliptin — DRUG
    New use 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
Mar 6, 2025
Completion
Mar 6, 2025

Study Design

Enrollment
26,126 participants (actual)

Arms

  • Arm: New use of oral semaglutide
    Exposure group
  • Arm: New use 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-

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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