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

The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone.

Inclusion Criteria: * Have been diagnosed with type 2 diabetes * Have received a stable dose of metformin monotherapy for at least 8 weeks prior to screening * If used any glucose-lowering drugs other than metformin within the 8 weeks prior to screening such use was ≤7 days and was discontinued at least 4 weeks prior to screening * Have HbA1c ≥7.5% to ≤11.0% (screening) and HbA1c ≥7.0% to ≤10.5% (pre-randomization) * Have fasting plasma glucose ≤13.9 mmol/L (screening and pre-randomization) * Have a body mass index ≥19.0 kg/m\^2 and ≤35.0 kg/m\^2 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