The purpose of this study is to evaluate the efficacy and safety of Berlim 25/10 association in the treatment of type 2 diabetes mellitus and dyslipidemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
Berlim 25/10 association coated tablet.
Empagliflozin 25 mg coated tablet.
Rosuvastatin 10 mg coated tablet.
Change from baseline in glycated hemoglobin (HbA1c) levels.
Time frame: 120 days
Percent change from baseline of LDL-c levels.
Time frame: 120 days
Incidence and severity of adverse events recorded during the study.
Time frame: 150 days
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Berlim 25/10 association placebo coated tablet.
Empagliflozin placebo coated tablet.
Rosuvastatin placebo coated tablet.