Clinical Trial

Early Add-On Combination of GLP-1 Receptor Agonist and SGLT2 Inhibitor in People With Cardiovascular-Kidney-Metabolic Stage 2-3

Study acronym: GLP1-SGLT2-CKM
Completed
View on ClinicalTrials.gov →
Summary
This retrospective observational target-trial emulation uses electronic health record data from the TriNetX US Collaborative Network to compare early treatment intensification strategies in adults with obesity, type 2 diabetes, and cardiovascular-kidney-metabolic stage 2-3 who initiate a GLP-1 receptor agonist or an SGLT2 inhibitor. The study compares patients who, within 90 days of starting background therapy, add the alternate agent, add a DPP-4 inhibitor or sulfonylurea, or do not receive early add-on therapy. The primary outcome is all-cause mortality over 36 months, with secondary cardiorenal outcomes also evaluated. Propensity-score methods are used to reduce bias from nonrandom treatment selection.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-08.
Trial Details
NCT Number NCT07465926
Lead Sponsor Chung Shan Medical University
Collaborators: National Science and Technology Council, Taiwan
Conditions Cardiovascular-kidney-metabolic Syndrome, Cardiovascular Disease Risk Factor, Kidney Disease, Type 2 Diabetes, Obesity & Overweight
Enrollment 451,036 participants
Start Date 2017-01-01
Primary Completion 2026-01-31 (estimated)
Study Completion 2026-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-22