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Metabolic SyndromePhase 3DEMETERNCT05905965

Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment

A Phase 3 study testing Empagliflozin 20 mg and Empagliflozin 10 mg in people with Metabolic Syndrome, run by Collegium Medicum w Bydgoszczy at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Metabolic Syndrome
What is being tested?
Empagliflozin 20 mg and Empagliflozin 10 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 sitePoland
Study dates
1 May 2023to 31 Mar 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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;
  • 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;
  • elevated non-high-density lipoprotein (non-HDL ≥130 mg/dL) cholesterol level (atherogenic dyslipidemia) or on lipid-lowering drug treatment

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Jacek Kubica, Prof. contact

+48 525854023

jkubica@cm.umk.pl

Poland1 site, 1 recruiting

  • Cardiology Department, Dr. A. Jurasz University Hospital

    Bydgoszcz, Cuiavian-Pomeranian, 85-094

    Jacek Kubica, prof., +48525854023, jkubica@cm.umk.pl

    Recruiting

Other trials in Poland

About this study

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

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.

Read more

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.
Read the detailed 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.

Other variables that are scheduled to be analyzed: central arterial pressure, pulse wave propagation speed, ABPM (ambulatory blood pressure monitoring), endothelial function assessment by Endopath, autonomic nervous system assessment (ANSA) by Task Force Touch CARDIO (TFTC), exercise tolerance, thickness of the adipose tissue (skin fold), blood samples: blood count, serum creatinine and eGFR, ALT, AST, GGTP, total cholesterol, HDL-C, uric acid, plasma concentration of calcium, phosphate, parathormon, 25-OH-D3, cystatin C, erythropoietin; morning urine: N-acetyl-beta-D-glucosaminidase, sodium/creatinine ratio, calcium/creatinine ratio, albumin/creatinine ratio. Moreover, functioning in chronic disease and adherence to medication and diet will be assessed with dedicated questionairies (FCIS, ACDS, ACDS diet).

Being tested
Empagliflozin 20 mg, Empagliflozin 10 mg
Keywords
metabolic syndrome, empagliflozin, adherence
Medical subject headings
Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empagliflozin 20 mgDrug

    Patients receiving empagliflozin 20 mg daily - experimental arm

  • Empagliflozin 10 mgDrug

    Patients receiving empagliflozin 10 mg daily - control arm

Study groups in NCT05905965
Study groupRoleWhat they receive
Empagliflozin 20 mgExperimentalPatients receiving empagliflozin 20 mg daily
Receives: Drug: Empagliflozin 20 mg
Empagliflozin 10 mgActive comparatorPatients receiving empagliflozin 10 mg daily
Receives: Drug: Empagliflozin 10 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BMI (Body Mass Index)

    change in BMI between study arms

    Measured: 0-6 months

  2. concentration of HbA1c (glycated hemoglobin)

    change in glycated hemoglobin plasma concentration between study arms

    Measured: 0-6 months

Secondary outcomes (21)

  1. concentration of LDL-C (low density cholesterol serum concentration)

    change in low density cholesterol serum concentration between study arms

    Measured: 0-6 months

  2. concentration of triglycerides

    change in triglycerides serum concentration between study arms

    Measured: 0-6 months

  3. concentration of CRP (c-reactive protein)

    change in CRP serum concentration between study arms

    Measured: 0-6 months

  4. concentration of NT-proBNP

    change in NT-pro BNP serum concentration between study arms

    Measured: 0-6 months

  5. LVEF - left ventricle ejection fraction (echocardiography)

    change in LVEF (presented in percentage) between study arms

    Measured: 0-6 months

  6. body composition analysis - body fat mass [kg]

    evaluation of body fat mass [kg] change throughout the study

    Measured: 0-6 months

  7. body composition analysis - body fat mass [%]

    evaluation of body fat mass [%] change throughout the study

    Measured: 0-6 months

  8. body composition analysis - lean body mass [kg]

    evaluation of lean body mass [kg] change throughout the study

    Measured: 0-6 months

  9. body composition analysis - lean body mass [%]

    evaluation of lean body mass [%] change throughout the study

    Measured: 0-6 months

  10. body composition analysis - skeletal muscle mass [kg]

    evaluation of skeletal muscle mass [kg] change throughout the study

    Measured: 0-6 months

  11. body composition analysis - total body water [liters]

    evaluation of total body water [liters] change throughout the study

    Measured: 0-6 months

  12. body composition analysis - total body water [%]

    evaluation of total body water [%] change throughout the study

    Measured: 0-6 months

  13. body composition analysis - extracellular water [liters]

    evaluation of extracellular water [liters] change throughout the study

    Measured: 0-6 months

  14. body composition analysis - extracellular water [%]

    evaluation of extracellular water [%] change throughout the study

    Measured: 0-6 months

  15. body composition analysis - hydration [%]

    evaluation of hydration [%] change throughout the study

    Measured: 0-6 months

  16. body composition analysis - visceral fat level [liters]

    evaluation of visceral fat level [liters] change throughout the study

    Measured: 0-6 months

  17. level of maximal oxygen uptake (VO2max) measured in ergospirometry

    change in VO2 max between study arms

    Measured: 0-6 months

  18. waist-hip ratio (WHR)

    change in waist-hip ratio between study arms

    Measured: 0-6 months

  19. liver steatosis assessment (LSA) by computed tomography (CT)

    evaluation of liver steatosis assessment (LSA) assessed with computed tomography (CT), between study arms throughout the study

    Measured: 0-6 months

  20. major adverse cardiovascular events - MACE

    rate of MACE (based on medical history: heart attack, stroke, death) between study arms throughout the study

    Measured: 0-6 months

  21. cardiovascular hospitalizations

    rate of cardiovascular hospitalizations between study arms

    Measured: 0-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study start1 May 2023
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05905965
Sponsor's protocol ID
DEMETER
Acronym
DEMETER
Status last verified
Aug 2024
First submitted
12 May 2023
Last updated
27 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Empagliflozin 20 mg and Empagliflozin 10 mg in people with Metabolic Syndrome, run by Collegium Medicum w Bydgoszczy at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jacek Kubica, Prof. (+48 525854023, jkubica@cm.umk.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BMI (Body Mass Index) (time frame: 0-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05905965.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.

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