Replication of the LEADER Diabetes Trial in Healthcare Claims

NCT03936049 · Completed

Last updated 2026-05-28

This study is testing whether a diabetes treatment approach similar to one used in a previous trial reduces the risk of stroke, heart attack, or death in people with diabetes.

Status Completed The study has finished.

Type Observational

Participants 168,690 people

Who can join Ages 50–120 · all sexes

Timeline Started 2017-09 · est. completion 2021-02

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT03936049 ↗

Description as written by the study sponsor.

Investigators are building an empirical evidence base for real world data through large-scale replication 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

Liraglutide Drug

Liraglutide dispensing claim is used as the exposure group
DPP-4 inhibitor Drug

DPP-4 inhibitor dispensing claim is used as the reference group

Main thing measured	Relative hazard of composite outcome of Stroke, MI, and Mortality
Sponsor	Brigham and Women's Hospital
Conditions studied	Diabetes
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03936049 ↗