NCT05905965 (DEMETER) is a Phase 3 clinical trial of Empagliflozin 20 mg in Metabolic Syndrome, sponsored by Collegium Medicum w Bydgoszczy.

Who is sponsoring NCT05905965?

NCT05905965 is sponsored by Collegium Medicum w Bydgoszczy.

What drugs are being tested in NCT05905965?

Interventions in NCT05905965: Empagliflozin 20 mg, Empagliflozin 10 mg.

What condition does NCT05905965 study?

NCT05905965 studies Metabolic Syndrome.

Is NCT05905965 still recruiting?

NCT05905965 is currently recruiting now. Last updated 27 August 2024.

Last reviewed 2024-08-27 · How we verify

NCT05905965: DEMETER

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment

Recruiting now Phase 3 Last updated 27 August 2024

What this trial tests

Phase 3 trial testing Empagliflozin 20 mg in Metabolic Syndrome in 200 participants. Currently enrolling.

Timeline

1 May 2023

Primary endpoint
31 December 2025

31 March 2026

Quick facts

Lead sponsor	Collegium Medicum w Bydgoszczy
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	1 May 2023
Primary completion	31 December 2025
Estimated completion	31 March 2026
Sites	1 location across Poland

Drugs / interventions tested

Empagliflozin 20 mg — full drug profile →
Empagliflozin 10 mg — full drug profile →

Conditions studied

Metabolic Syndrome — all drugs for Metabolic Syndrome →

Sponsor

Collegium Medicum w Bydgoszczy — full company profile →

Who can join

Adults 18 to 85, any sex, with Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

SGLT2 inhibitors: from glucose-lowering to cardiovascular benefits.
Preda A, Montecucco F, Carbone F, Carbone F, et al · · 2024 · cited 76× · PMID 38456601 · DOI 10.1093/cvr/cvae047

Verify or expand the search:

Other recruiting trials for Metabolic Syndrome

Currently open trials in the same condition.

NCT07501858 — Assessing the Association Between H. Pylori Persistence and the Severity of Insulin Resistance in Patients With Metaboli · recruiting
NCT06857929 — "Improving Health and Reducing Chronic Disease Risk in Middle-Aged Adults Through Nutrition" · NA · recruiting
NCT07237750 — iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss · NA · recruiting
NCT07406191 — WB-EMS Effects on Cardiometabolic Risk Factors · NA · recruiting
NCT07383220 — Effect of Electrical Stimulation and Exercise on Blood Flow in Patients With Resistant High Blood Pressure · NA · recruiting

Other Collegium Medicum w Bydgoszczy trials

Trials by the same sponsor.

NCT07203846 — Modulation of Gut MicroFLORA With Rifaximin to Reduce High Platelet Reactivity in Post-ACS Patients on Ticagrelor · Phase 4 · not yet recruiting
NCT07231939 — Use of Flozins (Empagliflozin/Dapagliflozin) for Prevention of AKI · recruiting
NCT05779059 — Prasugrel Or Ticagrelor De-escalation in NSTE-ACS · Phase 3 · unknown
NCT04718025 — Evaluation of Safety and Efficacy of Two Ticagrelor-based De-escalation Antiplatelet Strategies in Acute Coronary Syndro · Phase 3 · unknown
NCT05162456 — Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination Study in Patients After Organ Transplantat · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05905965 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Collegium Medicum w Bydgoszczy
Last refreshed: 27 August 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05905965.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing