For the treatment of adult type 2 diabetes
Conditions
Interventions
Sponsors
The Second Affiliated Hospital of Xingtai Medical College
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Gender: male; 2. Age: 18-45 years old (including critical value); 3. The researcher judged that the subjects with normal skin on the abdominal wall of the drug to be injected had no fat hyperplasia, skin depression, skin induration, scar, inflammation, edema, ulcer, infection, bleeding, etc; 4. Subjects with normal glucose tolerance (FPG > 3.9 mmol / L and = 50.0kg was between 19.0-24.0kg/m2 (BMI = weight (kg) / height 2 (M2)), including the critical value; 8. The subjects who understand and follow the experimental process voluntarily participate in the study and sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who are definitely allergic to all drugs or their preparations used in this study; 2. Patients with drug allergy or food allergy or special dietary requirements, history of allergic diseases or allergic constitution; 3. patients with family history of diabetes (first degree relatives, namely parents or siblings or children). 4. Patients with history of severe hypoglycemia; 5. Patients with history of syncope or blackness; 6. Patients with cardiovascular, endocrine, metabolic, lung, gastrointestinal, liver, kidney, blood system, immune system, nervous system diseases, mental disorders and other diseases that are clinically significant may affect drug absorption, distribution, metabolism, excretion or safety assessment, or may reduce compliance; 7. Patients with abnormal laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function) and clinical significance before the trial; 8. screening for hepatitis B surface antigen positive patients, or hepatitis C antibody or syphilis specific antibody or AIDS antibody test results are abnormal clinical significance; 9. Patients with abnormal ECG or vital signs (body temperature, pulse, blood pressure) and clinical significance (body temperature 37.5 degrees C); Pulse 100 beats / min; Systolic blood pressure 139 mmHg, diastolic blood pressure 89 mmHg; 10. The patients who had undergone any operation in the first 6 months were screened; 11. The patients who lost blood or donated more than 400 ml blood in the first 3 months, or who received blood or blood component infusion; 12. Patients (including placebo group) who have participated in any clinical trials of drugs or medical devices within 3 months before screening were calculated according to the last medication time; 13. The subjects who had received any vaccine within one month before screening; 14. Subjects who took any drugs within one month before taking the drugs in this study, including prescription drugs, over-the-counter drugs and herbal medicines; 15. Subjects with previous drug abuse history or positive urine drug screening; 16. Subjects who smoked more than 5 cigarettes or the same amount of tobacco per day within 3 months before the first administration or who could not quit smoking during the trial period; 17. Subjects who drank more than 14 cups per week within 28 days before the first administration (1 cup = 5 ounces (150ml) of wine = 12 ounces (360ml) of beer = 1.5 ounces (45ml) of spirits), or took any alcoholic products within 48 hours before the first administration, or whose alcohol breath test was more than 0.0mg/100ml; 18. Those who drink too much tea, coffee or caffeinated beverage (more than 8 cups per day, 1 cup = 200 ml) 14 days before the first administration, or eat grapefruit (grapefruit), or food or beverage rich in xanthine, or cannot stop eating food or beverage rich in xanthine (such as chocolate, tea, coffee, cola, etc.) 48 hours before administration and during the trial period or grapefruit (grapefruit) or grapefruit, and products containing grapefruit or grapefruit components (grapefruit juice, grapefruit juice, etc.); 19. Subjects who still need or plan to engage in strenuous physical activity or exercise 3 days before the first administration and during the study period; 20. Subjects (or their partners) have pregnancy plans from 2 weeks before administration to 3 months aft
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactGou Fengxue
The Second Affiliated Hospital of Xingtai Medical College
Outcome results
None listed