NCT04670666 Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus
| NCT ID | NCT04670666 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | EMS |
| Condition | Type 2 Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 270 participants |
| Start Date | 2024-11-18 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 270 participants in total. It began in 2024-11-18 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04670666 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 2 Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04670666 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 270 participants.
Is NCT04670666 currently recruiting?
Yes, NCT04670666 is actively recruiting participants. Contact the research team at pesquisa.clinica@ncfarma.com.br for enrollment information.
Where is the NCT04670666 trial being conducted?
This trial is being conducted at Hortolândia, Brazil.
Who is sponsoring the NCT04670666 clinical trial?
NCT04670666 is sponsored by EMS. The trial plans to enroll 270 participants.
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