Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

Inclusion Criteria:

• Have been diagnosed with type 2 diabetes

• Received a stable dose of metformin monotherapy for at least 8 weeks prior toscreening

• If used any glucose-lowering drugs other than metformin within the 8 weeks prior toscreening such use was ≤7 days and was discontinued at least 4 weeks prior toscreening

• 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 to ≤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 diabeticneuropathy, or diabetic foot

• Have been taking any weight loss medication or dietary supplement, have participatedin a weight loss program, or have adhered to a special diet within 12 weeks prior toscreening

• Have used insulin or an insulin analogue for more than 14 days within 12 monthsprior to screening

• Have used any hypoglycemic drug other than metformin during the 4-week run-in periodprior to randomization

• Have had weight gain or loss ≥5% during the 4-week run-in period prior torandomization