Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment - Trial NCT05905965
Access comprehensive clinical trial information for NCT05905965 through Pure Global AI's free database. This Phase 3 trial is sponsored by Collegium Medicum w Bydgoszczy and is currently Recruiting. The study focuses on Metabolic Syndrome. Target enrollment is 200 participants.
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Study Focus
Sponsor & Location
Collegium Medicum w Bydgoszczy
Timeline & Enrollment
Phase 3
May 01, 2023
Mar 31, 2025
Primary Outcome
BMI (Body Mass Index),concentration of HbA1c (glycated hemoglobin)
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05905965
Non-Device Trial