Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

Exclusion Criteria

• •Have type 1 diabetes
• •Have had any acute diabetic complications within 12 months prior to screening
• •Have had any Grade 3 hypoglycemic event within 12 months prior to screening
• •Have had proliferative retinopathy or macular degeneration, severe diabetic neuropathy, or diabetic foot
• •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 12 weeks prior to screening
• •Have used insulin or an insulin analogue for more than 14 days within 12 months prior to screening
• •Have used any hypoglycemic drug other than metformin during the 4-week run-in period prior to randomization
• •Have had weight gain or loss ≥5% during the 4-week run-in period prior to randomization
• •Have a history of refractory or recurrent urinary tract infections or genital infections