Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment

Recruiting now · Phase 3

Conditions studied: Metabolic Syndrome

In brief

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.

Key facts

Study ID

NCT05905965

Run by

Collegium Medicum w Bydgoszczy

People needed

200

Starts

2023-05-01

Expected to finish

2026-03-31

Last updated by the study team

2024-08-27

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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

You may not qualify if…

• 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
• 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

Where it is running

• Cardiology Department, Dr. A. Jurasz University Hospital — Bydgoszcz, Cuiavian-Pomeranian, Poland (enrolling)

Full record on ClinicalTrials.gov

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