RecruitingDyslipidemia Associated With Type II Diabetes Mellitus

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

Eligible age

18–85 yrs

Accepts

All genders

Locations

0 states

Healthy volunteers

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About this study

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.

Sponsor: EMS

You may qualify if…

✓ 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;
✓ Participants with high or very high cardiovascular risk according to the Brazilian guideline on the prevention of cardiovascular diseases in patients with diabetes (2017), which have not reached the goal of LDL-c ≤ 70 mg/dL or ≤ 50 mg/dL, respectively, with lifestyle changes, who are or aren't using low or moderate potency statins;
✓ BMI (body mass index) \> 19 Kg/m2 and ≤ 45 Kg/m2.

You may not qualify if…

✕ 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;
✕ Known hypersensitivity to the formula components used during the clinical trial;
✕ Type 1 diabetes mellitus;
✕ Fasting blood glucose \> 300 mg/dL;
✕ Risk factors for volume depletion;

Source: ClinicalTrials.gov · NCT04602754 · last updated 2025-12-08