Drug Interaction Study Between Dorzagliatin and Sitagliptin

Inclusion criteria

• Subjects diagnosed with T2DM within at least 3 months prior to screening
• Male and/or female subjects between the ages of 30 and 65 years, inclusive;
• Body Mass Index (BMI) of 19 to 38 kg/m2, inclusive;
• Fasting C-peptide test result >0.3 nmol/L (>0.90 ng/mL);
• HbA1c ≥7% and ≤10.5%;

Exclusion criteria

• Fasting blood glucose at screening or Day -1 ≤110 or ≥270 mg/dL;
• Type 1 diabetes mellitus;
• Reported incidence of severe or serious hypoglycemia within 3 months prior to screening;
• Known contraindications to sitagliptin;
• Clinically significant gastrointestinal disorder;
• History or symptoms of clinically significant cardiovascular disease within one year prior to screening;
• History of more than three urinary tract infections and/or more than three genital fungal infections in the last 12 months;
• Reported history of clinically significant central nervous system disease;
• Reported history of liver disease;
• Reported history of clinically significant renal disease;
• Estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73m2;
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis;
• Known or suspected malignancy;
• Any reported hypersensitivity or intolerance to sitagliptin;
• Antidiabetic treatment with insulin, sulfonylureas, thiazolidinediones or GLP-1 agonist within 3 months prior to screening;
• Systolic blood pressure <90 or >160 mmHg or diastolic blood pressure <60 or >100 mmHg at screening;
• A hospital admission or major surgery within 90 days prior to screening;
• Uncontrolled hypertriglyceridemia >500 mg/dL;
• Positive blood screen for HIV, hHBsAg, or hepatitis C antibody;
• Positive pregnancy test result;
• Female is breast-feeding or planning to become pregnant;
• Treated with any investigational drugs within 6 weeks prior to screening;
• Reported history of prescription drug abuse;
• Reported history of alcohol abuse;
• Reported history of donation or or acute loss of blood during the 90 days prior to screening;