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.
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…
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