NCT04670666
Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus
Recruiting · Phase 3 · EMS · registry updated 2025-12-08
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
The purpose of this study is to evaluate the efficacy and safety of Madalena association in the treatment of type 2 diabetes mellitus.
Inclusion
- 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
- 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;