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 — DRUGNew use of semaglutide injection dispensing claim is used as the exposure.
- New initiation of sitagliptin — DRUGNew 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 injectionExposure group
- Arm: New initiation of sitagliptinReference 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02120 | - |
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