Efficacy and Safety of Berlim 25/20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia.
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
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
Treatments tested in this trial
- BERLIM 25/20 ASSOCIATION
- EMPAGLIFLOZIN PLACEBO
- ROSUVASTATIN CALCIUM PLACEBO
- EMPAGLIFLOZIN
- ROSUVASTATIN CALCIUM
- BERLIM 25/20 ASSOCIATION PLACEBO
Treatment groups
228 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov