Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment
ConditionMetabolic Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCollegium Medicum w Bydgoszczy
About this trial
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.
Eligibility criteria
Qualifiers
high blood pressure (systolic blood pressure - in-office measurement: ≥ 130 and/or diastolic blood pressure ≥85 mm Hg or systolic blood pressure - ambulatory measurement: ≥130 and/or diastolic blood pressure ≥ 80 mm Hg) or on anti-hypertensive treatment;
impaired glucose metabolism (fasting glucose ≥100 mg/dL or ≥ 140 mg/dL after 120 min in oral glucose tolerance test or HbA1c ≥5.7%) or on glucose-lowering drug treatment;
elevated non-high-density lipoprotein (non-HDL ≥130 mg/dL) cholesterol level (atherogenic dyslipidemia) or on lipid-lowering drug treatment
Disqualifiers
current treatment with SGLT2 inhibitor
chronic kidney disease with estimated glomerular filtration rate (eGFR) < 30 mL/min or on dialysis
severely impaired liver function
known hypersensitivity to the active empagliflozin or to any of the excipients contained in Jardiance
Trial design
Treatments tested in this trial
- Empagliflozin 20 mg
- Empagliflozin 10 mg
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov