Diabetes
Conditions
Interventions
Group 1:TRTR
Group 2:RTRT
Sponsors
The Second Affiliated Hospital of Xingtai Medical College
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria for inclusion: 1. The patients voluntarily participated in the trial and signed the informed consent form (ICF); 2. Chinese healthy male subjects aged 18-45 years (including 18 and 45 years); 3. Body mass index [BMI = weight (kg) / height (m) 2] at screening: 19.0-24.0 kg / m2, including 19.0 and 24.0 kg / m2; 4. Patients with body weight >= 50.0 kg; 5. No family history of obesity and diabetes; 6. Patients with normal glucose tolerance [3.9 mmol / L (70.2 mg / dl) < fasting blood glucose < 6.1 mmol / L (101 mg / dl), and 2-hour postprandial blood glucose < 7.8 mmol / L (140 mg / dl)]; 7. Patients with sufficient venous access can establish blood collection channels according to the research plan; 8. Patients who had no family planning during the study period agreed to use reliable contraceptive measures during the study period until 6 months after the last administration of the trial drug, and had no sperm donation plan; 9. Patients who can communicate well with researchers and complete the study according to the research regulations.
Exclusion criteria
Exclusion criteria: 1. Patients with history of heart, liver, kidney, digestive tract, nervous system diseases and metabolic abnormalities (including but not limited to gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases) during screening; 2. Patients with abnormal and clinically significant vital signs, physical examination results, laboratory examination results, chest X-ray results and 12 lead ECG results judged by the researchers during screening; 3. Screening the patients with hypoglycemia history in the first 3 months; 4. Patients with severe infection or trauma within 4 weeks before screening or who had undergone surgery within 3 months before screening; 5. Patients with known severe allergies (such as allergic to more than three kinds of allergens, allergic asthma affecting the lower respiratory tract, allergies requiring glucocorticoid treatment) or those with known allergic history to the drug components used in this study; 6. Patients who had used any drugs (such as corticosteroids, danazol, diazoxide, diuretics, epinephrine, salbutamol, terbutaline, glucagon, growth hormone, thyroid hormone, beta blockers) that affect the hypoglycemic effect of insulin within 4 weeks before screening; 7. Patients with positive results of HBsAg and syphilis non-specific antibody, and patients with positive results of anti HIV, anti HCV and syphilis specific antibody >= 1.0 IU / L; 8. Patients who have used any prescription drugs, Chinese herbal medicines, over-the-counter drugs and health products (except routine vitamin supplements) within 2 weeks before screening; 9. Patients who donated more than or equal to 200 ml blood within 6 months before screening, or who had donated blood with any component, or whose total blood loss was more than or equal to 200 ml due to any reason, or who had a history of blood transfusion or use of blood products; 10. Patients with any type of anemia judged by the researcher (male: hemoglobin 0.0 mg / 100ml) during screening; 13. Patients who had a history of drug abuse within 6 months before screening or whose urine tests were positive for prohibited drugs (morphine, methamphetamine, ketamine, dimethylene dioxoamphetamine, tetrahydrocannabinol acid) during screening; 14. Patients with significant changes in diet or exercise habits in the first 3 months were screened; 15. Screening of patients who have participated in other clinical trials (drugs or medical devices, randomized and used research drugs or medical devices) within the first three months, or who plan to participate in other clinical trials during the trial period or within one month after the end of the trial; 16. Any patient with food allergy or special dietary requirements who can not comply with the unified diet (such as intolerance to standard food, intolerance to lactose, etc.); 17. Patients with history of needle and blood syncope, intolerance of venipuncture and / or difficulty in blood collection; 18. Patients who are not suitable for this trial according to the evaluation of researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t; | — |
Countries
China
Contacts
Public ContactGuo Fengxue
The Second Affiliated Hospital of Xingtai Medical College
Outcome results
None listed