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Emulation of the SOUL Diabetes Trial in Healthcare Claims

NCT06659718 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43650

Last updated 2025-05-25

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

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Oral semaglutide

New use of oral semaglutide dispensing claim is used as the exposure.

DRUG

Sitagliptin

New initiation of sitagliptin dispensing claim is used as the reference.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Shirley Wang, PhD, ScM · Brigham and Women's Hospital

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-24
Primary Completion
2025-02-13
Completion
2025-02-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT06659718 on ClinicalTrials.gov