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

Prior treatment

• Participation in a clinical trial in the year prior to this study;
• Participants with current treatment and continued for more than 15 days with systemic steroids at the time of informed consent;
• Medical history of acute coronary syndrome, stroke, unstable congestive heart failure, or respiratory failure within 6 months prior to informed consent;
• 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.

Other illness

• History of alcohol abuse or illicit drug use;
• Known hypersensitivity to the formula components used during the clinical trial;
• Type 1 diabetes mellitus;
• Impaired renal function and end-stage renal disease;
• 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;
• 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;

Lab values

• Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
• Fasting blood glucose \> 300 mg/dL;

Other

• Pregnancy or risk of pregnancy and lactating patients;
• Risk factors for volume depletion;
• Impaired hepatic function;

• 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.