Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment (DEMETER - SIRIO 11) Study

DEMETER

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.

2023-05-01

2024-12-31

2025-03-31

Recruiting

Early phase I

200

Inclusion Criteria: * diagnosis of metabolic syndrome as follows: the presence of obesity (waist circumference ≥ 88 cm in women; ≥102 cm or body mass index (BMI) ≥30 kg/m2) and two of the three following criteria: 1. 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; 2. 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; 3. elevated non-high-density lipoprotein (non-HDL ≥130 mg/dL) cholesterol level (atherogenic dyslipidemia) or on lipid-lowering drug treatment Exclusion Criteria: * current treatment with SGLT2 inhibitor * chronic kidney disease with estimated glomerular filtration rate (eGFR) \&lt; 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 * history of ketoacidosis * diabetes treated with insulin * pregnancy * decompensated heart failure * acute coronary syndrome * active thromboembolic disease * current treatment for neoplastic disease * active inflammatory disease within 1 month prior to enrollment * expected lifetime \<1 year * non-cooperative patients

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2023-06-15