Clinical Trial: Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment
Study Status: Completed
Recruit Status: RECRUITING
Condition: Metabolic Syndrome
Study Type: INTERVENTIONAL
Official Title: Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment (DEMETER - SIRIO 11) Study
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:Empagliflozin 20 mg - experimental armEmpagliflozin 10 mg - control arm.Primary co-endpoints of the study include: BMI and HbA1c.Secondary endpoints include: LDL-C, triglycerides, CRP,…
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