Health TrialsbyHealthPanel

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

ConditionDyslipidemia Associated With Type II Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorEMS

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;

Participants of both sexes, with age greater than or equal to 18 years and less than or equal to 85 years;

Participants presenting the diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goals of HbA1c with previous dietary, physical exercise guidance and previous therapies at a stable dose in the last 3 months;

HbA1c ≥ 7,5% and ≤ 10,5% and fasting blood glucose > 100 mg/dL at the screening visit;

Disqualifiers

Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;

History of alcohol abuse or illicit drug use;

Participation in a clinical trial in the year prior to this study;

Pregnancy or risk of pregnancy and lactating patients;

Trial design

Design model

Parallel

Treatments tested in this trial

  • BERLIM 25/20 ASSOCIATION

    Drug

    Berlim 25/20 association coated tablet.

  • EMPAGLIFLOZIN PLACEBO

    Other intervention

    Empagliflozin placebo coated tablet.

  • ROSUVASTATIN CALCIUM PLACEBO

    Other intervention

    Rosuvastatin calcium placebo coated tablet.

  • EMPAGLIFLOZIN

    Drug

    Empagliflozin 25 mg coated tablet.

  • ROSUVASTATIN CALCIUM

    Drug

    Rosuvastatin 20 mg coated tablet.

  • BERLIM 25/20 ASSOCIATION PLACEBO

    Other intervention

    Berlim 25/20 association placebo coated tablet.

Treatment groups

228 Participants
are divided into 2 treatment groups
Group A: BERLIM 25/20Experimental treatment 3 interventions
Group B: Empagliflozin + rosuvastatin calciumActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Reduction of glycated hemoglobin levels measured between the first visit and the last visit.

Time frame
120 days
2

Percentual reduction of LDL-c levels measured between the first visit and the last visit.

Time frame
120 days

Secondary outcomes

1

Incidence and severity of adverse events recorded during the study.

Time frame
150 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EMS

Lead sponsor

Source ClinicalTrials.gov
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