Emulation of the EMPEROR-Preserved Trial Using Healthcare Claims Data

NCT07599293 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 39614

Last updated 2026-05-20

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07599293 on ClinicalTrials.gov