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

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.