Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment

Sponsor
Collegium Medicum w Bydgoszczy
Study ID
NCT05905965
Phase
PHASE3
Status
Recruiting
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Conditions

  • Metabolic Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
May 1, 2023
Status verified
Aug 2024
Primary completion
Dec 31, 2025
Completion
Mar 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin 20 mg
    Patients receiving empagliflozin 20 mg daily
  • Active Comparator: Empagliflozin 10 mg
    Patients receiving empagliflozin 10 mg daily

Primary Outcome Measure

BMI (Body Mass Index) [ Time Frame: 0-6 months ]

Central Contacts

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