Emulation of the SOUL Diabetes Trial in Healthcare Claims

NCT06659718 · Completed

Last updated 2026-05-28

This study uses healthcare records to test whether a diabetes medication reduces the risk of heart attack, stroke, or death in adults with type 2 diabetes.

Status Completed The study has finished.

Type Observational

Participants 43,650 people

Who can join Ages 50+ · all sexes

Timeline Started 2024-10 · est. completion 2025-02

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT06659718 ↗

Description as written by the study sponsor.

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.

Treatments tested

Oral semaglutide Drug

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

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

Main thing measured	Major adverse cardiac event (MACE), including myocardial infarction, stroke and all cause death
Sponsor	Brigham and Women's Hospital
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06659718 ↗