Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment

NCT05905965 | Recruiting Phase 3 DMC

• 1 other identifier: DEMETER
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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. 1.Empagliflozin 20 mg - experimental arm
2. 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.

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome; empagliflozin; adherence

Outcome Measures

Primary Outcomes (2)

• BMI (Body Mass Index)

  change in BMI between study arms

  0-6 months

• concentration of HbA1c (glycated hemoglobin)

  change in glycated hemoglobin plasma concentration between study arms

  0-6 months

Secondary Outcomes (21)

• concentration of LDL-C (low density cholesterol serum concentration)

  0-6 months

• concentration of triglycerides

  0-6 months

• concentration of CRP (c-reactive protein)

  0-6 months

• concentration of NT-proBNP

  0-6 months

• LVEF - left ventricle ejection fraction (echocardiography)

  0-6 months

Study Arms (2)

Empagliflozin 20 mg

EXPERIMENTAL

Patients receiving empagliflozin 20 mg daily

Drug: Empagliflozin 20 mg

Empagliflozin 10 mg

ACTIVE COMPARATOR

Patients receiving empagliflozin 10 mg daily

Drug: Empagliflozin 10 mg

Interventions

Empagliflozin 20 mg DRUG

Patients receiving empagliflozin 20 mg daily - experimental arm

Empagliflozin 20 mg

Empagliflozin 10 mg DRUG

Patients receiving empagliflozin 10 mg daily - control arm

Empagliflozin 10 mg

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Collegium Medicum w Bydgoszczy: lead

Study Sites (1)

Cardiology Department, Dr. A. Jurasz University Hospital

Bydgoszcz, Cuiavian-Pomeranian, 85-094, Poland

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jacek Kubica, Prof.

  Collegium Medicum w Bydgoszczy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacek Kubica, Prof.

CONTACT

+48 525854023; jkubica@cm.umk.pl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr hab.

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: June 15, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)