The purpose of this study is to evaluate the efficacy and safety of Atenas association in the treatment of type 2 diabetes mellitus and hypertension
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
ATENAS 1 coated tablet, once a day EMPAGLIFLOZIN PLACEBO Empagliflozin placebo 1 coated tablet, once a day TELMISARTAN + AMLODIPINE PLACEBO Telmisartan + amlodipine 1 coated tablet, once a day
Drug: EMPAGLIFLOZIN Empagliflozin 25 mg 1 coated tablet, once a day. Drug: TELMISARTAN Telmisartan + Amlodipine 40 + 5/80 +5 mg 1 coated tablet, once a day ATENAS PLACEBO Atenas placebo 1 coated tablet, once a day
Glycated hemoglobin
Changes from baseline in glycated hemoglobin
Time frame: 120 days
Systolic blood pressure (SBP)
Changes from baseline in SBP in ambulatory blood pressure monitoring
Time frame: 120 days
Adverse events
Incidence and severity of adverse events recorded during the study
Time frame: 150 days
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