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.
1 other identifier
interventional
228
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2023
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2020
CompletedFirst Posted
Study publicly available on registry
October 26, 2020
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
ExpectedDecember 8, 2025
December 1, 2025
2.4 years
October 21, 2020
December 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Reduction of glycated hemoglobin levels measured between the first visit and the last visit.
120 days
Percentual reduction of LDL-c levels measured between the first visit and the last visit.
120 days
Secondary Outcomes (1)
Incidence and severity of adverse events recorded during the study.
150 days
Study Arms (2)
BERLIM 25/20
EXPERIMENTALThe study is triple-dummy. The patient must take 3 tablets once a day, as follows: 1 tablet Berlim 25/20 association, oral; 1 tablet empagliflozin placebo, oral; 1 tablet rosuvastatin calcium placebo, oral.
Empagliflozin + rosuvastatin calcium
ACTIVE COMPARATORThe patient must take 3 tablets once a day, as follows: 1 tablet Berlim 25/20 association placebo, oral; 1 tablet empagliflozin, oral; 1 tablet rosuvastatin calcium, oral.
Interventions
Berlim 25/20 association placebo coated tablet.
Eligibility Criteria
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;
- Participants with total cholesterol \> 500 mg/dL or triglycerides \> 500 mg/dL;
- Impaired renal function and end-stage renal disease;
- Participants with known heart failure, class III to IV (New York Heart Association);
- Impaired hepatic function;
- Medical history of pancreatic diseases that may suggest insulin deficiency;
- Participants who had any cardiovascular event (acute myocardial infarction, acute coronary syndrome, recent onset stable angina, stroke, unstable congestive heart failure requiring treatment change), underwent revascularization or vascular surgery in the 6 months prior to screening;
- Bariatric surgery in the last two years and/ or other gastrointestinal surgeries that can cause chronic malabsorption syndrome;
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EMSlead
Study Sites (1)
Allergisa
Campinas, São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2020
First Posted
October 26, 2020
Study Start
December 1, 2023
Primary Completion
May 1, 2026
Study Completion (Estimated)
September 1, 2027
Last Updated
December 8, 2025
Record last verified: 2025-12