A Phase 2 Study of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Diet and Exercise

Exclusion Criteria

• •Have type 1 diabetes mellitus or specific type of diabetes mellitus (pancreatic injury-induced diabetes mellitus, diabetes mellitus caused by Cushing's syndrome or acromegaly, etc.)
• •Have had diabetic ketoacidosis or hyperglycemic hyperosmolar state within 6 months prior to screening
• •Have had 2 or more Grade 3 hypoglycemic events within 12 months prior to screening
• •Have unstable or treatment-requiring proliferative retinopathy or macular degeneration, severe diabetic neuropathy, diabetic foot, or intermittent claudication within 6 months prior to screening
• •Have been taking any weight loss medication or dietary supplement, have participated in a weight loss program, or have adhered to a special diet within 4 weeks prior to screening
• •Have continuously used insulin or an insulin analogue for more than 14 days within 12 months prior to screening
• •Have used 2 or more classes of hypoglycemic medications for more than 8 weeks within 12 months prior to screening
• •Have used any glucose-modifying medications within 8 weeks prior to screening
• •Have had weight gain or loss ≥5% from screening to randomization