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NCT05905965

Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment

Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment (DEMETER - SIRIO 11) Study
Collegium Medicum w Bydgoszczy·Phase 3·ClinicalTrials.gov·drugRecruiting
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Study focus
Disease/Condition
Metabolic Syndrome
Drug/Device/Intervention
Empagliflozin 20 mg
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Collegium Medicum w Bydgoszczy
Location
Bydgoszcz, Poland
Timeline & enrollment
Phase
Phase 3
Start date
May 01, 2023
End date
Mar 31, 2025
Enrollment
200 participants
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
Metabolic disordersMetabolic disorder, unspecifiedOther metabolic disordersOther specified metabolic disordersNutritional and metabolic disorders in diseases classified elsewhere
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05905965
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.