Phase 3 Study of Madalena Association for Treating Type 2 Diabetes in Adults

What this Trial Is About

Researchers are evaluating the efficacy and safety of the Madalena association in treating adults with type 2 diabetes mellitus who have not achieved their blood sugar goals with diet, exercise, and dual anti-hyperglycemic therapy. This phase III, randomized, double-blind study compares Madalena association with a combination of metformin, empagliflozin, and linagliptin to better understand its impact on blood sugar control. Participants take three tablets once daily according to their assigned group one group receives the Madalena association tablet plus placebos for the other treatments, while the other group takes metformin and empagliflozin plus linagliptin tablets with a Madalena placebo. The study uses a triple-dummy design to keep treatment assignments blinded and monitors outcomes over about 120 to 150 days. During the study, participants will have their glycated hemoglobin HbA1c levels measured after 120 days to assess blood sugar control changes. Safety is monitored by recording any side effects or adverse events over approximately 150 days. Participants will attend regular visits for evaluations, blood tests, and adherence checks to ensure accurate monitoring of treatment effects and safety throughout the trial.

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