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RECRUITING
NCT04602754
PHASE3

Efficacy and Safety of Berlim 25/20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia.

Sponsor: EMS

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of Berlim 25/20 association in the treatment of type 2 diabetes mellitus and dyslipidemia.

Official title: National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Berlim 25/20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia.

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

228

Start Date

2023-12-01

Completion Date

2027-09

Last Updated

2025-12-08

Healthy Volunteers

No

Interventions

DRUG

BERLIM 25/20 ASSOCIATION

Berlim 25/20 association coated tablet.

OTHER

EMPAGLIFLOZIN PLACEBO

Empagliflozin placebo coated tablet.

OTHER

ROSUVASTATIN CALCIUM PLACEBO

Rosuvastatin calcium placebo coated tablet.

DRUG

EMPAGLIFLOZIN

Empagliflozin 25 mg coated tablet.

DRUG

ROSUVASTATIN CALCIUM

Rosuvastatin 20 mg coated tablet.

OTHER

BERLIM 25/20 ASSOCIATION PLACEBO

Berlim 25/20 association placebo coated tablet.

Locations (1)

Allergisa

Campinas, São Paulo, Brazil