Emulation of the EMPEROR-Preserved Trial Using Healthcare Claims Data
NCT07599293 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 39614
Last updated 2026-05-20
Summary
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.
Conditions
Interventions
- DRUG
-
Sitagliptin
Initiation of sitagliptin described in electronic health records is used as the reference.
- DRUG
-
Empagliflozin
Initiation of empagliflozin described in electronic health records is used as the exposure.
Sponsors & Collaborators
-
Food and Drug Administration (FDA)
collaborator FED -
Brigham and Women's Hospital
lead OTHER
Principal Investigators
-
Shirley Wang, PhD, ScM · Brigham and Women's Hospital
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-13
- Primary Completion
- 2026-06-01
- Completion
- 2026-06-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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