Comparing two doses of empagliflozin for treating metabolic syndrome

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

This study is testing whether two different doses of empagliflozin can help people with metabolic syndrome improve their weight and blood sugar levels.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Collegium Medicum w Bydgoszczy (Academic / other)
• Locations: 1 site (Bydgoszcz, Cuiavian-Pomeranian)
• Trial ID: NCT05905965 on ClinicalTrials.gov

What this trial studies

The DEMETER - SIRIO 11 study is a phase III, multicenter, randomized, open-label clinical trial designed to evaluate the efficacy of two different doses of empagliflozin in patients diagnosed with metabolic syndrome. A total of 200 participants will be randomly assigned to receive either 20 mg of empagliflozin or 10 mg for a duration of six months. The primary outcomes will focus on changes in body mass index (BMI) and HbA1c levels, while secondary outcomes will assess various cardiovascular and metabolic parameters. This study aims to provide insights into the optimal dosing of empagliflozin for improving health outcomes in this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with metabolic syndrome who meet specific inclusion criteria related to obesity, blood pressure, glucose metabolism, and cholesterol levels.

Not a fit: Patients currently on SGLT2 inhibitors or those with severe kidney or liver impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of metabolic syndrome, potentially reducing associated health risks.

How similar studies have performed: Other studies have shown promising results with empagliflozin in managing metabolic syndrome, indicating that this approach is supported by prior evidence.

Eligibility criteria

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) \< 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 this trial is running

Bydgoszcz, Cuiavian-Pomeranian

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

Study contacts

• Principal investigator: Jacek Kubica, Prof. — Collegium Medicum w Bydgoszczy
• Study coordinator: Jacek Kubica, Prof.

Conditions Metabolic Syndrome; metabolic syndrome; empagliflozin; adherence