drugset / Trial / NCT03932721

EXpanded Combination of Evolocumab Plus Empagliflozin on Diabetes: EXCEED-BHS3 Trial

NCT03932721

Phase 4 Completed 110 enrolled University of Campinas, Brazil
RandomizedParallel-groupSingle-blindDiagnostic

Summary

Based on the current evidence, empagliflozin could reduce cardiovascular morbidity and mortality in Diabetes Mellitus Type 2 (T2DM). Anti-PCSK9 therapy (evolocumab) can reduce the major cardiovascular events incidence in secondary prevention individuals, some of them presenting T2DM. The beneficial effect of the combined use of these two agents in T2DM remains unknown. Evaluating the effect of evolocumab on top of the best of care therapy for T2DM, including empaglifozin, on endothelial function may indicate the existence of some benefit related to cardiovascular outcomes.

Timeline

Start
2018-10-01
Primary completion
2021-06-30
Completion
2021-10-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Evolocumab Monoclonal antibody 140 mg