Effects Of Berberine Plus Inulin On Diabetes Care in Patients With LADA

Prior treatment

• Evidence of acute or chronic infection affecting glycemic control within 4 weeks prior to the first visit;
• Chronic use of systemic glucocorticoids or other immunosuppressive agents for over 3 months，or use of antibiotic medications or other interventions that could affect the gastrointestinal tract for 2 months before the screening and during the whole study period.

Other illness

• History of any malignancy;
• Secondary diabetes;
• Severe organic heart disease, including but not limited to congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, etc., New York Heart Association (NYHA) heart function classification ≥Grade III;
• Allergic to berberine or any components in the combinations.

Lab values

• Severe liver dysfunction (ALT and AST greater than 3 times the upper limit of detection);
• eGFR \< 50ml/(min • 1.73 m2);
• History of hemolytic anemia or glucose-6-phosphate dehydrogenase deficiency.

Other

• Pregnancy, breastfeeding, or planned pregnancy during the study period;
• Presence of acute complications (ketoacidosis, lactic acidosis or hyperosmolar coma);

• Diabetes diagnosed according to the report of WHO in 1999；
• Meet the Chinese Diabetes Society diagnostic criteria (2012) for LADA: (1)glutamic acid decarboxylase antibody (GADA) positive; (2) age at diagnosis ≧ 18 years old; (3) independent on insulin for more than 6 months after diagnosis;
• Aged between 18 and 70 years old;
• 7.0%≤HbA1c ≤10.0%;
• BMI ≥ 18.5 kg/m2, and no more than 37.5 kg/m2;
• Written informed consent from the patient or family representative.