Inclusion Criteria:  Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the consent form; Diagnosis of type II diabetes mellitus, and who did not reach the therapeutic goal of HbA1c with previous dietary, physical exercise, and previous therapies at stable doses within 3 months.  Exclusion Criteria:  Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of 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 pregnacy and lactating participants; Known hypersensitivity to any of the formula compounds; Type 1 diabetes.