Dyslipidemia Associated With Type II Diabetes MellitusPhase 3NCT04602754
Efficacy and Safety of Berlim 25/20 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia.
A Phase 3 study testing BERLIM 25/20 ASSOCIATION, EMPAGLIFLOZIN and ROSUVASTATIN CALCIUM in people with Dyslipidemia Associated With Type II Diabetes Mellitus, run by EMS at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Dyslipidemia Associated With Type II Diabetes Mellitus
- What is being tested?
- BERLIM 25/20 ASSOCIATION, EMPAGLIFLOZIN and ROSUVASTATIN CALCIUM
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2023to Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- Condition that, in the investigator's judgment, may favor clinically significant changes in CPK levels;
- Current medical history of cancer and/ or cancer treatment in the last 5 years;
- Participants with known uncontrolled hypothyroidism or TSH levels > 5 mIU/L;
- History of known muscle disease or prior statin intolerance;
- Participants using SGLT2 inhibitors, sulfonylureas and/or insulin therapy or PCSK9 inhibitors;
- Participants who used other medications with prominent action in the control of serum triglyceride and cholesterol levels in the last 4 weeks or who are using low or moderate-intensity statins that cannot be replaced by rosuvastatin 20 mg;
- Participants using medications that may interfere with triglyceride and cholesterol metabolism started less than 4 weeks ago or with dose adjustment in the last 4 weeks prior to the screening visit;
- Treatment with anti-obesity drugs for less than 2 months or with dose change in the last 2 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Allergisa
Campinas, São Paulo
Mauro A Crippa, MD
About this study
Official title: 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.
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.
- Being tested
- BERLIM 25/20 ASSOCIATION, EMPAGLIFLOZIN PLACEBO, ROSUVASTATIN CALCIUM PLACEBO, EMPAGLIFLOZIN, ROSUVASTATIN CALCIUM
- Keywords
- Dyslipidemia, Type II Diabetes Mellitus
- Medical subject headings
- Dyslipidemias, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BERLIM 25/20 ASSOCIATIONDrug
Berlim 25/20 association coated tablet.
EMPAGLIFLOZIN PLACEBOOther
Empagliflozin placebo coated tablet.
ROSUVASTATIN CALCIUM PLACEBOOther
Rosuvastatin calcium placebo coated tablet.
EMPAGLIFLOZINDrug
Empagliflozin 25 mg coated tablet.
ROSUVASTATIN CALCIUMDrug
Rosuvastatin 20 mg coated tablet.
BERLIM 25/20 ASSOCIATION PLACEBOOther
Berlim 25/20 association placebo coated tablet.
| Study group | Role | What they receive |
|---|---|---|
| BERLIM 25/20 | Experimental | The 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. Receives: Drug: BERLIM 25/20 ASSOCIATION; Other: EMPAGLIFLOZIN PLACEBO; Other: ROSUVASTATIN CALCIUM PLACEBO |
| Empagliflozin + rosuvastatin calcium | Active comparator | The 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. Receives: Drug: EMPAGLIFLOZIN; Drug: ROSUVASTATIN CALCIUM; Other: BERLIM 25/20 ASSOCIATION PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of glycated hemoglobin levels measured between the first visit and the last visit.
Measured: 120 days
Percentual reduction of LDL-c levels measured between the first visit and the last visit.
Measured: 120 days
Secondary outcomes (1)
Incidence and severity of adverse events recorded during the study.
Measured: 150 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start1 Dec 2023
- Primary completionMay 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyslipidemia Associated With Type II Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602754
- Sponsor's protocol ID
- EMS1019 - Berlim 25/20
- Status last verified
- Dec 2025
- First submitted
- 21 Oct 2020
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04602754
- Acronym / sponsor ID
- EMS1019 - Berlim 25/20
- Keywords
- Dyslipidemia, Type II Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BERLIM 25/20 | Experimental | Drug: BERLIM 25/20 ASSOCIATION, Other: EMPAGLIFLOZIN PLACEBO, Other: ROSUVASTATIN CALCIUM PLACEBOThe 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 comparator | Drug: EMPAGLIFLOZIN, Drug: ROSUVASTATIN CALCIUM, Other: BERLIM 25/20 ASSOCIATION PLACEBOThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BERLIM 25/20 ASSOCIATIONBerlim 25/20 association coated tablet. | Drug | BERLIM 25/20 |
| EMPAGLIFLOZIN PLACEBOEmpagliflozin placebo coated tablet. | Other | BERLIM 25/20 |
| ROSUVASTATIN CALCIUM PLACEBORosuvastatin calcium placebo coated tablet. | Other | BERLIM 25/20 |
| EMPAGLIFLOZINEmpagliflozin 25 mg coated tablet. | Drug | Empagliflozin + rosuvastatin calcium |
| ROSUVASTATIN CALCIUMRosuvastatin 20 mg coated tablet. | Drug | Empagliflozin + rosuvastatin calcium |
| BERLIM 25/20 ASSOCIATION PLACEBOBerlim 25/20 association placebo coated tablet. | Other | Empagliflozin + rosuvastatin calcium |
Primary outcome
Reduction of glycated hemoglobin levels measured between the first visit and the last visit.
Time frame: 120 days
Percentual reduction of LDL-c levels measured between the first visit and the last visit.
Time frame: 120 days
1 secondary outcome
Incidence and severity of adverse events recorded during the study.
Time frame: 150 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BERLIM 25/20 ASSOCIATION, EMPAGLIFLOZIN and ROSUVASTATIN CALCIUM in people with Dyslipidemia Associated With Type II Diabetes Mellitus, run by EMS at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cassiano O Berto, BD (+551938877724, pesquisa.clinica@ncfarma.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of glycated hemoglobin levels measured between the first visit and the last visit. (time frame: 120 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.