A Phase 1, Open-Label, Sequential, Multiple-Dose, Drug-Drug Interaction Study of Dorzagliatin and Sitagliptin in Subjects With Type 2 Diabetes Mellitus

HMM0111

This is a Phase 1, open-label, sequential, multiple-dose, drug interaction study of glucokinase activator dorzagliatin and sitagliptin in subjects with T2DM. Pharmacokinetics and pharmacodynamics when dorzagliatin and sitagliptin given alone and in combination will be studied.

2019-01-31

2019-08-30

2019-08-30

Completed

Early phase I

15

Inclusion Criteria: 1. Subjects diagnosed with T2DM within at least 3 months prior to screening 2. Male and/or female subjects between the ages of 30 and 65 years, inclusive; 3. Body Mass Index (BMI) of 19 to 38 kg/m2, inclusive; 4. Fasting C-peptide test result \>0.3 nmol/L (\>0.90 ng/mL); 5. HbA1c ≥7% and ≤10.5%; Exclusion Criteria: 1. Fasting blood glucose at screening or Day -1 ≤110 or ≥270 mg/dL; 2. Type 1 diabetes mellitus; 3. Reported incidence of severe or serious hypoglycemia within 3 months prior to screening; 4. Known contraindications to sitagliptin; 5. Clinically significant gastrointestinal disorder; 6. History or symptoms of clinically significant cardiovascular disease within one year prior to screening; 7. History of more than three urinary tract infections and/or more than three genital fungal infections in the last 12 months; 8. Reported history of clinically significant central nervous system disease; 9. Reported history of liver disease; 10. Reported history of clinically significant renal disease; 11. Estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73m2; 12. Acute or chronic metabolic acidosis, including diabetic ketoacidosis; 13. Known or suspected malignancy; 14. Any reported hypersensitivity or intolerance to sitagliptin; 15. Antidiabetic treatment with insulin, sulfonylureas, thiazolidinediones or GLP-1 agonist within 3 months prior to screening; 16. Systolic blood pressure \<90 or \>160 mmHg or diastolic blood pressure \<60 or \>100 mmHg at screening; 17. A hospital admission or major surgery within 90 days prior to screening; 18. Uncontrolled hypertriglyceridemia \>500 mg/dL; 19. Positive blood screen for HIV, hHBsAg, or hepatitis C antibody; 20. Positive pregnancy test result; 21. Female is breast-feeding or planning to become pregnant; 22. Treated with any investigational drugs within 6 weeks prior to screening; 23. Reported history of prescription drug abuse; 24. Reported history of alcohol abuse; 25. Reported history of donation or or acute loss of blood during the 90 days prior to screening;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}

2023-02-28