Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus

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.

Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus (NCT04670666) is a Phase 3 interventional studying Type 2 Diabetes Mellitus, sponsored by EMS. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Type 2 Diabetes Mellitus, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 270 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Type 2 Diabetes Mellitus subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the willing to sign a consent form 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 Should NOT Join This Trial: - 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; - 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 willing to sign a consent form; - 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 willing to sign a consent form; - Current medical history of cancer and/ or cancer treatment in the last 5 years; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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. Exclusion Criteria: * 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; * 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.

Treatments Being Tested

DRUG

MADALENA ASSOCIATION

Madalena association coated tablet.

DRUG

METFORMIN

Metformin 1000 mg extended-release tablet.

DRUG

EMPAGLIFLOZIN + LINAGLIPTIN

Empagliflozin 10 mg + linagliptin 5 mg coated tablet.

OTHER

MADALENA ASSOCIATION PLACEBO

Madalena association placebo tablet.

OTHER

METFORMIN PLACEBO

Metformin placebo tablet.

OTHER

EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO

Empagliflozin + linagliptin placebo tablet.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

EMS

Hortolândia, São Paulo, Brazil

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04670666), the sponsor (EMS), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04670666 clinical trial studying?

The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04670666?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04670666?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04670666. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04670666. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.