Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus
Trial Parameters
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; *