a single-dose and multiple-dose study to evaluate the pharmacokinetics and pharmacodynamics of dbpr108 tablets in type 2 diabetes mellitus patients

Conditions: Type 2 Diabetes Mellitus

Summary: this is a phase i study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-dose and multiple-dose of dbpr108 tablets in type 2 diabetes mellitus patients.

this study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics, single-dose and multiple-dose of dbpr108 tablets in chinese type 2 diabetes mellitus patients. the 30 eligible patients will be randomized to receive 50 mg, 100 mg, or 200 mg dbpr108 tablets.

Eligibility criteria:
inclusion criteria: 1. patients who meet the world health organization (who) (1999) criteria for the diagnosis and classification criteria for type 2 diabetes mellitus; 2. 18 ≤ age ≤ 75 years old, male or female; 3. body mass index (bmi) within the range of 19-35 kg/m\^2 (inclusive), bmi = weight (kg) / height\^2 (m\^2); 4. 7.0% ≤hemoglobin a1c (hba1c) ≤ 9.5%; 5. patients who voluntarily participate in the study and sign the informed consent form; 6. patients who agree to use contraception from the signing of the informed consent form until 1 month after the end of the last medication. exclusion criteria: 1. fasting plasma glucose (fpg) \> 13.9 mmol/l; 2. the investigator determines that the patients need to use insulin therapy; 3. patients with acute or serious complications of diabetes (including diabetic ketoacidosis, hyperosmotic nonketotic diabetic coma, lactic acidosis and hypoglycemia coma); 4. history of severe hypoglycemia (hypoglycemia with severe cognitive impairment and requiring other measures to help recover); 5. history of acute or chronic pancreatitis, or related diseases that are most common cause of acute pancreatitis (such as recurrent cholelithiasis, etc.); 6. history of allergy to dpp-4 inhibitors or the investigator determines that the patients may be allergic to investigational drug; 7. patients with untreated hyperthyroidism and other diseases, which may affect blood glucose; 8. patients who have used other hypoglycemic drugs within 14 days before the first dose; or patients who are not suitable for this study as determined by the investigator due to taking other hypoglycemic drugs; 9. patients with inflammatory bowel disease, partial intestinal obstruction or chronic bowel disease related to obvious digestive and absorption disorders; 10. aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 3 \* upper limit of normal (uln), or total bilirubin \> 1.5 \*uln; 11. abnormal renal function: serum creatinine\>1.5 \* uln; or egfr\< 45 ml/min/1.73m\^2; 12. white blood cells (wbc) \ 5.7 mmol/l; 13. patients who have the second or third degree atrioventricular block, long q-t syndrome, or qtc\>500 ms without cardiac pacemaker; 14. patients with any one of hbsag, hepatitis c antibody, anti-hiv antibody and antibody of treponema pallidum positive; 15. female patients of childbearing age with pregnant test positive or lactating women; 16. history of alcohol or drug abuse within 3 months before screening, alcohol abuse is average alcohol intake more than 14 units alcohol (1 unit=12 ounces or 360 ml of beer,1.5 ounces or 45 ml spirits with 40% alc/vol, 5 ounces or 150 ml grape wine); or intake any other products containing alcohol within 2 days before the first administration of investigational product; 17. patients who smoke more than 5 cigarettes per day within 3 months prior to screening; 18. patients with consumption of grapefruit juice, methylxanthine-rich food or beverage (such as coffee, tea, cola, chocolate, energy drinks) within 2 days before the first administration in treatment period , or patients who have strenuous exercise, or have other factors affecting drug absorption, distribution, metabolism, excretion, etc; 19. participation in other clinical trials or administration of any other investigational drugs or devices within 3 months before screening; 20. patients with the following diseases: 1. serious dysrhythmias, obvious left ventricular dysfunction, new york heart association (nyha) functional class iii or iv; 2. history of unstable angina pectoris, myocardial infarction, or other high-risk coronary artery diseases; 3. uncontrolled hypertension, systolic pressure ≥160 mmhg or diastolic pressure ≥100 mmhg; 4. history of cancer , organ transplantation; 5. history of epilepsy, psychosis, severe depression, etc. 21. not suitable for this study as determined by the investigator due to other reasons.