Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment

Recruiting Phase 3 Interventional Study
Metabolic Syndrome
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Collegium Medicum w Bydgoszczy · Other
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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 …
Trial Locations
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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…
Contacts

Jacek Kubica, Prof.

+48 525854023

jkubica@cm.umk.pl

CONTACT