Type 2 Diabetes Mellitus
Conditions
Interventions
Experimental group:Semaglutide injection, specification: 1.34 mg/mL, 1.5 mL, a single fasting administration of 0.25 mg, abdominal subcutaneous injection
Positive control:Ozempic, specification: 1.34 mg/mL, 1.5 mL (pre-filled injection pen), a single fasting administration of 0.25 mg, abdominal subcutaneous injection
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria to be enrolled in the study: 1. Voluntarily participate in the trial and sign the informed consent; Willing and able, in the investigator's judgment, to comply with all experimental requirements and restrictions; 2. Healthy men and women, aged 18 to 55 years old (including the end value); 3. Body mass index (BMI) 19.0~25.0 kg/m2 (including end value), weight =50.0 kg; 4. Physical examination, vital signs, 12-lead electrocardiogram (ECG), clinical laboratory examination, no clinically significant abnormalities; 5. For female subjects of reproductive age, consent to use physical contraception (e.g., IUD, diaphragm, etc.) from 14 days before screening until 1 month after the end of the trial, and the pregnancy test results during the screening period must be negative. Women of reproductive age are defined as: after menarche, have not reached postmenopausal status (postmenopausal status is defined as: continuous amenorrhea for =12 months, and no other cause other than menopause is found), and have not undergone sterilization (removal of ovaries and/or uterus); 6. For male subjects, condoms must be used during the study period until 1 month after the end of the study, and sperm donation must be avoided during this period, or their fertile female partner must use the effective contraceptive methods listed above.
Exclusion criteria
Exclusion criteria: Exclusion criteria: Subjects who meet any of the following criteria will be excluded: 1. Have a history of clinically serious disease or currently have any clinically significant cardiovascular, metabolic, endocrine, kidney, liver, gastrointestinal, hematological, respiratory, cutaneous, neurological, gynecological, psychiatric or other disease; 2. A history of medullary thyroid carcinoma (MTC), multiple endocrine adenoma (MEN) 2A or 2B syndrome, or related family history; Or other malignant tumor history; 3. Any major surgery within 3 months prior to screening. Major surgery is defined as surgery on the intracranial, chest, abdomen, pelvic, or limb organs that results in major trauma to the tissue and requires long-term recovery (e.g., organ transplant, heart surgery, or joint replacement); 4. Acute bacterial or viral infection or other hypercatabolic state (such as severe infection, trauma, burn, etc.) within 2 weeks before administration; 5. Patients with clinically significant abnormal gastric empelation (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (such as active ulcers within 6 months), long-term use of drugs that have a direct impact on gastrointestinal motility (including but not limited to moxapriride, cisapriride, etc.), or gastrointestinal surgery within 3 months before screening were assessed by the investigators as not suitable to participate in this clinical study; 6. Subjects with a history of acute and chronic pancreatitis, symptomatic gallbladder history (such as multiple gallstones, etc.), pancreatic injury history and other high-risk factors that may lead to pancreatitis; 7. In the screening period, calcitonin was greater than the upper limit of normal; 8. Patients with HBA1C greater than 6.5% during the screening period; 9. Those who smoked more than 5 cigarettes per day in the 3 months before screening and those who could not smoke during the whole test period; 10. Those who have a history of alcohol abuse (drinking more than 14 units of alcohol per week, 1 unit of about 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine) in the six months prior to screening, or who cannot abstain from alcohol during the test period; 11. Those who have used any prescription drugs, experimental drugs, Chinese medicines and their preparations within 2 weeks prior to screening, or are still within 5 half-lives; 12. Those who have used any non-prescription drugs (including dietary supplements and medicinal skin creams) within 1 week before screening; 13. Consume any food or drink containing caffeine, alcohol, xanthine or grapefruit (such as coffee, strong tea, chocolate, etc.) within 48 hours before check-in; 14. Known or suspected allergy to semaglutide injection or similar products and excipients; 15. Participants in clinical trials of any approved or unapproved investigational drug/device within 90 days prior to screening (or within 5 half-lives after the last dose, whichever is longer) (excluding those who have signed informed consent but not given to any operator); 16. Pregnant and lactating female subjects; 17. Patients with difficulty in venous blood collection; 18. Those who were vaccinated within 4 weeks prior to screening or planned to be vaccinated during the trial; 19. People who donate blood or lose more than 400 mL of blood or receive blood transfusions or use blood products in the 3 months prior to screening; 20. Patients who have previously received Semaglutide injection or oth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-inf;AUC0-t;Cmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK;AE;ADA; | — |
Countries
CHINA
Contacts
Public ContactWei Hu
The Second Hospital of Anhui Medical University
Outcome results
None listed