ABO-GLYC in Type 2 Diabetes

Inclusion criteria

• Male and female patients with diagnosis of type 2 diabetes, aged 18-75
• HbA1c at screening between 6.5% and 7.5%
• Last 2 HbA1c values in the last 12 months between 6.5% and 7.5%
• Intolerance to metformin without unquestionable indication to other oral hypoglycemic agents
• BMI 25-38 kg/m2
• Willing and able to understand and sign the informed consent and complete the patient diary provided
• Women participant of childbearing age should be negative to pregnancy test (performed on blood), and will have to use an appropriate contraceptive method throughout the study.

Exclusion criteria

• Micro and macrovascular complication of diabetes in advanced stage (i.e., proliferative diabetic retinopathy; chronic renal failure III-IV stage KDOQI)
• Chronic gastro-intestinal disease
• Heavy smoker subjects
• Alcohol abuse
• Chronic liver and kidney disease (AST or ALT values > 2.5 UNL or plasma creatinine > 1.5 mg/dl)
• Previous major gastrointestinal surgery
• History of eating disorders
• Pregnancy or lactation
• Use of food supplements containing in particular but not limited to fibers and polysaccharides, in the last six months with frequency and dosage such as to interfere with the study.
• Autoimmune diseases
• Known hypersensitivity to any of the components of the product.
• Any condition which prevent subject participation in the opinion of the principal investigator.