Replication of the LEAD-2 Diabetes Trial in Healthcare Claims Data

NCT05162183 · Completed

Last updated 2026-05-28

This study tests how well a diabetes treatment works in real-world settings by measuring changes in blood sugar levels over 26 weeks in people with diabetes.

Status Completed The study has finished.

Type Observational

Participants 3,474 people

Who can join Ages 18–80 · all sexes

Timeline Started 2019-09 · est. completion 2021-09

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT05162183 ↗

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

Glimepiride Drug

Glimepiride dispensing claim is used as the reference group.
Liraglutide Drug

Liraglutide dispensing claim is used as the exposure group.

Main thing measured	Relative Hazard of change in HbA1c from baseline to 26 weeks of treatment (end of follow-up)
Sponsor	Brigham and Women's Hospital
Conditions studied	Diabetes
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05162183 ↗