Type 2 Diabetes MellitusPhase 3NCT04603508
Efficacy and Safety of Berlim 25/10 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia
A Phase 3 study testing BERLIM 25/10 association, EMPAGLIFLOZIN and ROSUVASTATIN CALCIUM in people with Type 2 Diabetes Mellitus and Dyslipidemia, run by EMS.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Berlim 25/10 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
- Type 2 Diabetes Mellitus, Dyslipidemia
- What is being tested?
- BERLIM 25/10 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
- 240 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Aug 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 low or intermediary 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 ≤ 100 mg/dL with lifestyle changes, who are or aren't using low-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;
- 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-intensity statins that cannot be replaced by rosuvastatin 10 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
No sites are listed yet.
About this study
Official title: National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Berlim 25/10 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 25/10 association in the treatment of type 2 diabetes mellitus and dyslipidemia.
- Conditions
- Type 2 Diabetes Mellitus, Dyslipidemia
- Being tested
- BERLIM 25/10 association, EMPAGLIFLOZIN, ROSUVASTATIN CALCIUM, BERLIM 25/10 ASSOCIATION PLACEBO, EMPAGLIFLOZIN PLACEBO
- Keywords
- Dyslipidemia, Type II Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BERLIM 25/10 associationDrug
Berlim 25/10 association coated tablet.
EMPAGLIFLOZINDrug
Empagliflozin 25 mg coated tablet.
ROSUVASTATIN CALCIUMDrug
Rosuvastatin 10 mg coated tablet.
BERLIM 25/10 ASSOCIATION PLACEBOOther
Berlim 25/10 association placebo coated tablet.
EMPAGLIFLOZIN PLACEBOOther
Empagliflozin placebo coated tablet.
ROSUVASTATIN CALCIUM PLACEBOOther
Rosuvastatin placebo coated tablet.
| Study group | Role | What they receive |
|---|---|---|
| Berlim 25/10 | Experimental | The study is triple-dummy. The patient must take 3 tablets once a day, as follows:
1 tablet Berlim 25/10 association, oral;
1 tablet empagliflozin placebo, oral;
1 tablet rosuvastatin calcium placebo, oral. Receives: Drug: BERLIM 25/10 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 25/10 association placebo, oral;
1 tablet empagliflozin , oral;
1 tablet rosuvastatin calcium, oral. Receives: Drug: EMPAGLIFLOZIN; Drug: ROSUVASTATIN CALCIUM; Other: BERLIM 25/10 ASSOCIATION PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in glycated hemoglobin (HbA1c) levels.
Measured: 120 days
Percent change from baseline of LDL-c levels.
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 startMar 2023 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603508
- Sponsor's protocol ID
- EMS0919 - Berlim 25/10
- Status last verified
- Aug 2022
- First submitted
- 21 Oct 2020
- Last updated
- 5 Aug 2022
- 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 5 Aug 2022. 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 25/10 Association in the Treatment of Type II Diabetes Mellitus and Dyslipidemia.
- ClinicalTrials.gov ID
- NCT04603508
- Acronym / sponsor ID
- EMS0919 - Berlim 25/10
- Conditions
- Type 2 Diabetes Mellitus, Dyslipidemia
- Keywords
- Dyslipidemia, Type II Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Mar 2023 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Aug 2025 (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 25/10 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 25/10 | Experimental | Drug: BERLIM 25/10 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 25/10 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 25/10 ASSOCIATION PLACEBOThe patient must take 3 tablets once a day, as follows: 1 tablet Berlim 25/10 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 low or intermediary 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 ≤ 100 mg/dL with lifestyle changes, who are or aren't using low-potency statins;
Key exclusion criteria (22 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 25/10 associationBerlim 25/10 association coated tablet. | Drug | Berlim 25/10 |
| EMPAGLIFLOZINEmpagliflozin 25 mg coated tablet. | Drug | Empagliflozin + rosuvastatin calcium |
| ROSUVASTATIN CALCIUMRosuvastatin 10 mg coated tablet. | Drug | Empagliflozin + rosuvastatin calcium |
| BERLIM 25/10 ASSOCIATION PLACEBOBerlim 25/10 association placebo coated tablet. | Other | Empagliflozin + rosuvastatin calcium |
| EMPAGLIFLOZIN PLACEBOEmpagliflozin placebo coated tablet. | Other | Berlim 25/10 |
| ROSUVASTATIN CALCIUM PLACEBORosuvastatin placebo coated tablet. | Other | Berlim 25/10 |
Primary outcome
Change from baseline in glycated hemoglobin (HbA1c) levels.
Time frame: 120 days
Percent change from baseline of LDL-c levels.
Time frame: 120 days
1 secondary outcome
Incidence and severity of adverse events recorded during the study.
Time frame: 150 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BERLIM 25/10 association, EMPAGLIFLOZIN and ROSUVASTATIN CALCIUM in people with Type 2 Diabetes Mellitus and Dyslipidemia, run by EMS.
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 22 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: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monalisa FB Oliveira, MD (+551938879851, 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?
Change from baseline in glycated hemoglobin (HbA1c) levels. (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 5 Aug 2022.