RecruitingPhase 3Drug trial
Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment
The DEMETER - SIRIO 11 study is a phase III, multicenter, randomized, open-labled, investigator-initiated clinical trial with a 6 month follow-up.
The study population will include 200 subjects with diagnosis of metabolic syndrome.
All enrolled patients (nn=200) will be randomly assigned in 1:1 ratio to one of the two study arms:
1. Empagliflozin 20 mg - experimental arm
2. Empagliflozin 10 mg - control arm. Primary co-endpoints of the study include: BMI and HbA1c. Secondary endpoints include: LDL-C, triglycerides, CRP, NT-proBNP, LVEF (echocardiography), body composition, VO2max (ergospirometry), waist-hip ratio (WHR), liver steatosis assessment (LSA) by computed tomography (CT), major adverse cardiovascular events - MACE (based on medical history: heart attack, stroke, death), cardiovascular hospitalizations.