drugset / Trial / NCT03639545

The Effects of Empagliflozin on Arterial Wall Characteristics

NCT03639545

Phase 4 Unknown 120 enrolled University Medical Centre Ljubljana
RandomizedParallel-groupTriple-blindTreatment

Summary

Introduction: Diabetes mellitus is characterized by impaired arterial function and high incidence of cardiovascular events. Metformin and most recent antidiabetic groups of drugs, SGLT2 inhibitors, were in previous studies shown to reduce cardiovascular events. Until now, direct effect of empagliflozin on arterial function and its comparison to metformin was not studied yet. Aim: The aim of the present study is to explore and compare potential direct effects of empagliflozin and metformin on arterial functional and structural arterial wall characteristics in patients with type 1 diabetes mellitus. Methods: Patients with type 1 diabetes mellitus are randomized into four groups: 1) empagliflozin (25 mg daily), 2) metformin (2000 mg daily), 3) combination (empagliflozin 25 mg daily and metformin 2000 mg daily) and 4) control (placebo). At inclusion and after 12 weeks treatment, arterial function is assessed: endothelial function (brachial artery flow-mediated dilation (FMD), reactive hyperemia index (RHI)) and arterial stiffness (carotid pulse wave velocity (PWV), carotid-femoral PWV (cfPWV) and common carotid artery stiffness (β-stiffness)).

Timeline

Start
2018-03-01
Primary completion
2018-12-30
Completion
2019-01-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Empagliflozin Small molecule 25 mg Oral
Comparator Metformin Small molecule 2000 mg Oral