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

NCT04602754 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2025-12-08

No results posted yet for this study

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.

Conditions

  • Dyslipidemia Associated With Type II Diabetes Mellitus

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.

Sponsors & Collaborators

  • EMS

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2026-05-31
Completion
2027-09-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04602754 on ClinicalTrials.gov