Type 2 Diabetes MellitusPhase 3NCT04670666
Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus
A Phase 3 study testing MADALENA ASSOCIATION, METFORMIN and EMPAGLIFLOZIN + LINAGLIPTIN in people with Type 2 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 Madalena association in the treatment of type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- MADALENA ASSOCIATION, METFORMIN and EMPAGLIFLOZIN + LINAGLIPTIN
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Nov 2024to Jun 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 years and older
- 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 with 18 years of age or greater;
- 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 at least 3 months with two anti-hyperglycemic agents (dual therapy);
- HbA1c ≥ 7,5% and ≤ 10,5% and fasting blood glucose > 100 mg/dL at the screening visit;
- 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;
- Impaired renal function and end-stage renal disease;
- Participants with current treatment and continued for more than 15 days with systemic steroids at the time of informed consent;
- 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;
- Medical history of acute coronary syndrome, stroke, unstable congestive heart failure, or respiratory failure within 6 months prior to informed consent;
- Current medical history of cancer and/ or cancer treatment in the last 5 years;
- Medical history of metabolic acidosis and/or using drugs that may cause lactic acidosis;
- Medical history of blood dyscrasia or any other hemolytic disorders;
- Participants using sulfonylureas and/or insulin therapy;
- 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.
About this study
Official title: National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus.
The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- MADALENA ASSOCIATION, METFORMIN, EMPAGLIFLOZIN + LINAGLIPTIN, MADALENA ASSOCIATION PLACEBO, METFORMIN PLACEBO
- Keywords
- Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MADALENA ASSOCIATIONDrug
Madalena association coated tablet.
METFORMINDrug
Metformin 1000 mg extended-release tablet.
EMPAGLIFLOZIN + LINAGLIPTINDrug
Empagliflozin 10 mg + linagliptin 5 mg coated tablet.
MADALENA ASSOCIATION PLACEBOOther
Madalena association placebo tablet.
METFORMIN PLACEBOOther
Metformin placebo tablet.
EMPAGLIFLOZIN + LINAGLIPTIN PLACEBOOther
Empagliflozin + linagliptin placebo tablet.
| Study group | Role | What they receive |
|---|---|---|
| MADALENA | Experimental | The study is triple-dummy. The patient must take 3 tablets once a day, as follows:
1 tablet Madalena association, oral;
1 tablet empagliflozin + linagliptin association placebo, oral;
1 tablet metformin placebo, oral. Receives: Drug: MADALENA ASSOCIATION; Other: METFORMIN PLACEBO; Other: EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO |
| Metformin + empagliflozin + linagliptin | Active comparator | The patient must take 3 tablets once a day, as follows:
1 tablet Madalena association placebo, oral;
1 tablet empagliflozin + linagliptin association, oral;
1 tablet metformin, oral. Receives: Drug: METFORMIN; Drug: EMPAGLIFLOZIN + LINAGLIPTIN; Other: MADALENA 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
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 posted17 Dec 2020
- Study start18 Nov 2024
- Primary completionJul 2026 (estimated)
- Study completionJun 2027 (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
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670666
- Sponsor's protocol ID
- EMS1419 - MADALENA
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 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 Madalena Association in the Treatment of Type II Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT04670666
- Acronym / sponsor ID
- EMS1419 - MADALENA
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 17 Dec 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 Madalena association in the treatment of type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MADALENA | Experimental | Drug: MADALENA ASSOCIATION, Other: METFORMIN PLACEBO, Other: EMPAGLIFLOZIN + LINAGLIPTIN PLACEBOThe study is triple-dummy. The patient must take 3 tablets once a day, as follows: 1 tablet Madalena association, oral; 1 tablet empagliflozin + linagliptin association placebo, oral; 1 tablet metformin placebo, oral. |
| Metformin + empagliflozin + linagliptin | Active comparator | Drug: METFORMIN, Drug: EMPAGLIFLOZIN + LINAGLIPTIN, Other: MADALENA ASSOCIATION PLACEBOThe patient must take 3 tablets once a day, as follows: 1 tablet Madalena association placebo, oral; 1 tablet empagliflozin + linagliptin association, oral; 1 tablet metformin, oral. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
- Participants with 18 years of age or greater;
- 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 at least 3 months with two anti-hyperglycemic agents (dual therapy);
- HbA1c ≥ 7,5% and ≤ 10,5% and fasting blood glucose > 100 mg/dL at the screening visit;
- BMI (body mass index) > 19 Kg/m2 and ≤ 45 Kg/m2.
Key exclusion criteria (20 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 |
|---|---|---|
| MADALENA ASSOCIATIONMadalena association coated tablet. | Drug | MADALENA |
| METFORMINMetformin 1000 mg extended-release tablet. | Drug | Metformin + empagliflozin + linagliptin |
| EMPAGLIFLOZIN + LINAGLIPTINEmpagliflozin 10 mg + linagliptin 5 mg coated tablet. | Drug | Metformin + empagliflozin + linagliptin |
| MADALENA ASSOCIATION PLACEBOMadalena association placebo tablet. | Other | Metformin + empagliflozin + linagliptin |
| METFORMIN PLACEBOMetformin placebo tablet. | Other | MADALENA |
| EMPAGLIFLOZIN + LINAGLIPTIN PLACEBOEmpagliflozin + linagliptin placebo tablet. | Other | MADALENA |
Primary outcome
Change from baseline in glycated hemoglobin (HbA1c) 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
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 MADALENA ASSOCIATION, METFORMIN and EMPAGLIFLOZIN + LINAGLIPTIN in people with Type 2 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 5 inclusion and 20 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 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). 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.