RecruitingPhase 3NCT04602754

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

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.


Sponsor

EMS

Enrollment

228 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination drug called Berlim 25/20 (which combines two medications that lower blood sugar and cholesterol) in people with Type 2 diabetes and high cholesterol who have not achieved adequate blood sugar or cholesterol control with their current treatment. **You may be eligible if...** - You are between 18 and 85 years old - You have Type 2 diabetes with HbA1c (3-month blood sugar average) between 7.5% and 10.5% - You have high cardiovascular risk and have not reached LDL cholesterol goals despite current treatment - Your BMI is between 19 and 45 - You have been on stable diabetes and/or cholesterol-lowering medication for the past 3 months **You may NOT be eligible if...** - You have Type 1 diabetes - You have significant health conditions that would interfere with the study in the investigator's judgment - You have a history of alcohol or drug abuse - You are currently in another clinical trial - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBERLIM 25/20 ASSOCIATION

Berlim 25/20 association coated tablet.

OTHEREMPAGLIFLOZIN PLACEBO

Empagliflozin placebo coated tablet.

OTHERROSUVASTATIN CALCIUM PLACEBO

Rosuvastatin calcium placebo coated tablet.

DRUGEMPAGLIFLOZIN

Empagliflozin 25 mg coated tablet.

DRUGROSUVASTATIN CALCIUM

Rosuvastatin 20 mg coated tablet.

OTHERBERLIM 25/20 ASSOCIATION PLACEBO

Berlim 25/20 association placebo coated tablet.


Locations(1)

Allergisa

Campinas, São Paulo, Brazil

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NCT04602754


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