Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment

NCT ID: NCT05905965

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2026-03-31

Brief 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.

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).

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Empagliflozin 20 mg

Patients receiving empagliflozin 20 mg daily

Group Type: EXPERIMENTAL

Empagliflozin 20 mg

Intervention Type: DRUG

Patients receiving empagliflozin 20 mg daily - experimental arm

Empagliflozin 10 mg

Patients receiving empagliflozin 10 mg daily

Group Type: ACTIVE_COMPARATOR

Empagliflozin 10 mg

Intervention Type: DRUG

Patients receiving empagliflozin 10 mg daily - control arm

Interventions

Empagliflozin 20 mg

Patients receiving empagliflozin 20 mg daily - experimental arm

Intervention Type: DRUG

Empagliflozin 10 mg

Patients receiving empagliflozin 10 mg daily - control arm

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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:

1. 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;

2. 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;

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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Collegium Medicum w Bydgoszczy

OTHER

Sponsor Role: lead

Responsible Party

Jacek Kubica

Prof. dr hab.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacek Kubica, Prof.

Role: PRINCIPAL_INVESTIGATOR

Collegium Medicum w Bydgoszczy

Locations

Cardiology Department, Dr. A. Jurasz University Hospital

Bydgoszcz, Cuiavian-Pomeranian, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Jacek Kubica, Prof.

Role: CONTACT

jkubica@cm.umk.pl

+48 525854023

Facility Contacts

Jacek Kubica, prof.

Role: primary

jkubica@cm.umk.pl

+48525854023

Other Identifiers

DEMETER

Identifier Type: -

Identifier Source: org_study_id