Type 2 Diabetes Mellitus
Conditions
Interventions
Test group:Single subcutaneous injection of Semaglutide developed by Hui Sheng Bio-pharmaceutical
Control group:Single subcutaneous injection of Ozempic developed by Novo Nordisk
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy subjects aged between 18 and 45 years old (both inclusive); 2. During the screening, the results of vital signs, physical examination, laboratory assessments and electrocardiograms are assessed as normal or unnormal, but without clinical meaning; 3. Male body weight is >= 50kg, female body weight is >= 45kg, and body mass index (BMI) is between 19.0 and 25.0kg /m^2 (both inclusive); 4. Abdominal skin of the drug injections is normal, without fatty hyperplasia, skin sag, skin induration, scar, inflammation, edema, ulcer, infection and bleeding, etc; 5. Fasting plasma glucose is >= 3.9 mmol/L and <6.1 mmol/L; HbA1c (glycosylated haemoglobin) is <6.5 %; 6. To voluntarily agree to take effective contraceptive methods within 2 months from signing the informed consent to administering the treatment drug; 7. Subjects understand and follow the study procedures, voluntarily participate the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Any positive results come from tests including human immunodeficiency virus antibody, hepatitis b surface antigen, hepatitis c antibody, syphilis specific antibody and anti-insulin antibody; 2. A history of drug allergy and severe atopic allergic disease, or is known to be allergic to semaglutide or its excipients or the same class drugs; 3. Recurrent episodes (>=3 times within 1 year) of hypoglycemia; 4. A history of fainting from needles or blood or difficulty with blood drawing; 5. The calcitonin level is above the upper limit of normal; 6. Any clinical significant disease or medical history evaluated by researchers, or any disease that could potentially affect drug absorption, distribution, metabolism, excretion, safety evaluation, or decrease the compliance, such as cancer, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine, hematological, dermatological, reproductive, neurological, or mental diseases, etc., including but not limited to acute and chronic pancreatitis, cholelithiasis, cholecystitis, medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN 2) medical or family history, or subjects with hereditary diseases that are prone to induce medullary thyroid carcinoma; 7. A family history of diabetes; 8. Any major surgery within 3 months before screening, defined as surgery targeting the brain, chest, abdomen, pelvic cavity or limb organs, resulting in major tissue trauma and requiring long-term recovery; 9. Use of any prescription drugs within 4 weeks before screening/baseline or within 5 half lives of drugs (based on whichever is longer), use of any over-the-counter drugs, traditional Chinese medicine or Chinese herbal medicine, health products (except nutritional supplements such as regular doses of vitamins) within 2 weeks before screening/baseline, receiving any vaccination within 4 weeks before screening/baseline or planning to vaccinate during the study period; 10. blood donation or blood loss >= 400 ml within 3 months before screening/baseline; 11. Subjects smoke more than 5 cigarettes per day within 3months before screening/baseline, or are unwilling to quit smoking during the trial; 12. The average daily pure alcohol consumption exceeded 25g (equivalent to 750 mL of beer or 250 mL of wine or 50g of liquor) within 3 months before screening/baseline, or the blood alcohol test was positive before the screening/randomization, or alcohol prohibition was not allowed during the test; 13. Intake of any food or beverage containing ingredients of caffeine, alcohol, xanthine, or grapefruit (such as coffee, strong tea, chocolate, etc.) within 3 days before screening/basline; 14. A history of drug abuse, or the results of drug abuse before screening/randomization are positive; 15. Subjects who have enrolled in any drug/medical device clinical trial within 3 months before screening or plan to participate in other clinical trials during this study; 16. Subjects who have a birth plan during the trial and within 2 months after the administration of the treatment drug; 17. Pregnant or lactating women; 18. Subjects who have serious metal illness or language disorder, and are unwilling or unable to fully understand or disorder; or unwilling or unable to follow the lifestyle described in the study protocol; 19. Subjects are those from study center or the sponsor who directly participate in the trial or their immediate family members (spouses, parents / legal guardians, siblings or chil
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of semaglutide;AUC (0-t) of semaglutide;AUC(0-8) of semaglutide; | — |
Countries
China
Contacts
Public ContactWei Hu
The Second Hospital of Anhui Medical University
Outcome results
None listed