This product is used to improve the blood sugar control of patients with type 2 diabetes. It is suitable for patients with metformin and sulfonylureas alone, and metformin combined with sulfonylureas,
Conditions
Interventions
Group A:TR2R1
Group B:R1TR2
Group C:R2R1T
Sponsors
The Second Affiliated Hospital of Xingtai Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Gender: Chinese healthy male or female subjects with appropriate gender ratio; 2. Age: 18~60 years old (including boundary value); 3. Male subjects should not be less than 50.0kg, female subjects should not be less than 45.0kg, and body mass index (BMI): 19.0~26.0kg/m2 (including boundary values, body mass index (BMI) = body weight ( kg) / height 2 (m2)); 4. The screening results of glucose tolerance test meet the following two points at the same time:blood glucose value before glucose tolerance test <6.1mmol/L; 2-hour glucose tolerance test result <7.8mmol/L; 5. Subjects must give informed consent to the study before the trial, and voluntarily sign the written informed consent; the subjects can communicate well with the investigator and complete the study in accordance with the protocol.
Exclusion criteria
Exclusion criteria: 1. Allergic constitution or history of drug or food allergy, or known allergy to exenatide; 2. The investigator believes that there are clinically significant diseases such as liver, kidney, endocrine, skin or metabolic disorders or any other diseases, or have a medical history of these diseases, or have a history of major surgery, or will endanger the subject's health. safety or factors affecting the results of the study; 3. Physical examination (especially the skin at the administration site), vital signs measurement, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function, blood pregnancy, serum virology, glucose tolerance test, insulin release test, glycosylated hemoglobin Examination), 12-lead ECG examination, abdominal CT examination results judged by the investigator to have clinical significance; 4. During the trial and within 3 months after the end of the study, the subject or his partner has a pregnancy plan or is unwilling to use medically acceptable contraceptive methods, or the subject has a sperm/egg donation plan; 5. Pregnant, lactating women, or women of childbearing age who did not take appropriate contraceptive measures within 14 days before enrollment, or who used oral contraceptives within 30 days before the first dose of the study, or who used long-acting estrogen or pregnancy within 3 months before the test Hormone injections or embedded tablets; 6. Has a history of drug abuse, or positive drug abuse and drug tests, or habitually taking any drugs (including Chinese herbal medicine) or functional vitamins; 7. Use of any prescription drugs, over-the-counter drugs, health products or Chinese herbal medicines within 14 days before screening; 8. Excessive smoking (>=5 cigarettes/day) within 3 months before screening, or smoking within 48 hours before the first dose of the study or a positive smoke test at screening, or the test period cannot be interrupted; 9. Previous alcoholism [that is, men drink more than 28 standard units per week and women drink more than 21 standard units per week (1 standard unit contains 14g of alcohol, such as 360ml of beer or 45ml of 40% alcohol or 150ml of wine) ], or frequent drinking (more than 14 standard units of alcohol per week) within 3 months before screening, or alcohol breath test results at screening greater than 0.0 mg/100 mL, or ingesting any alcohol-containing alcohol within 48 hours before the first dose of the study Food or beverages (such as liquor, beer, wine, rice wine, beer duck, fermented bean curd, egg yolk pie and Swiss roll with edible alcohol, etc.), or cannot be interrupted during the test 10. Long-term drinking of excessive caffeinated beverages (more than 8 cups a day, 1 cup = 250mL), or intake of any caffeinated food or beverage within 48 hours before the first dose of the study (such as: coffee, tea, cola, Chocolate, etc.), or the intake cannot be interrupted during the test; 11. Within 48 hours before the first dose of the study, take any grapefruit fruit or products containing grapefruit, or the intake cannot be interrupted during the test; 12. There are special requirements for diet and cannot comply with the unified diet; 13. Have started a significantly abnormal diet (such as diet, low sodium) within 4 weeks before screening; 14. Participated in other clinical trials within 3 months before screening; 15. Have been vaccinated within 1 month before screening; 16. Blood donation or massive blood loss (>=200mL) wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum blood concentration;The area under the plasma concentration-time curve from 0 to the last time point t;Area under the plasma concentration-time curve from zero to infinity; | — |
Countries
China
Contacts
Public ContactGuo Fengxue
The Second Affiliated Hospital of Xingtai Medical College
Outcome results
None listed