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Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment

ConditionMetabolic Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCollegium Medicum w Bydgoszczy

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Empagliflozin 20 mg

    Drug

    Patients receiving empagliflozin 20 mg daily - experimental arm

  • Empagliflozin 10 mg

    Drug

    Patients receiving empagliflozin 10 mg daily - control arm

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Empagliflozin 20 mgExperimental treatment 1 intervention
Group B: Empagliflozin 10 mgActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

BMI (Body Mass Index)

change in BMI between study arms

Time frame
0-6 months
2

concentration of HbA1c (glycated hemoglobin)

change in glycated hemoglobin plasma concentration between study arms

Time frame
0-6 months

Secondary outcomes

1

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

change in low density cholesterol serum concentration between study arms

Time frame
0-6 months
2

concentration of triglycerides

change in triglycerides serum concentration between study arms

Time frame
0-6 months
3

concentration of CRP (c-reactive protein)

change in CRP serum concentration between study arms

Time frame
0-6 months
4

concentration of NT-proBNP

change in NT-pro BNP serum concentration between study arms

Time frame
0-6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Collegium Medicum w Bydgoszczy

Lead sponsor

Source ClinicalTrials.gov
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