Type 2 Diabetes Mellitus
Conditions
Interventions
TR group:Phase 1: Injection of insulin degludec/insulin aspart developed by Hui Sheng Bio-pharmaceutical
Phase 2: Injection of Ryzodeg produced by Novo Nordisk
RT Group:Phase 1: Injection of Ryzodeg produced by Novo Nordisk
Phase 2: Injection of insulin degludec/insulin aspart developed by Hui Sheng Bio-pharmaceutical
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
21 Years to 37 Years
Inclusion criteria
Inclusion criteria: 1. Healthy subjects 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 =50kg, female body weight is =45kg, and body mass index (BMI) is between 19.0 and 25.0kg /m2 (both inclusive); 4. The researcher assesses that the 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 venous glucose <6.1 mmol/L; HbA1c (glycosylated haemoglobin) <6.5 %; insulin antibody is negative; 6. To voluntarily agree to take effective contraceptive methods within 1 month from signing the informed consent to the last injection of the treatment drug; 7. Subjects understand and follow the study procedures, voluntarily participate the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria are not eligible for this study: 1. Any positive results comes 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 treatment drugs or their excipients or same class drugs; 3. History of hypoglycemia episodes; 4. Any clinically significant diseases assessed by the researcher, past or present, on cardiovascular, endocrine, metabolic, pulmonary, gastrointestinal, liver, kidney, blood, nervous disease, psychological disorder or other diseases that would play a negative role in drug absorption, distribution, metabolism, excretion, and safety assessment or compliance. Besides, the researcher considers that there is a safety risk for subjects to participate in the study, or not suitable to participate in the study; 5. Use of any prescription drug within 4 weeks before this study (or still within 5 half lives of any prescription drug), use of any over-the-counter drug, traditional Chinese medicine or Chinese herbal medicine, health care products (except nutritional supplements such as vitamins) within 2 weeks before administration, and any vaccination received within 4 weeks before administration; 6. Blood donation or blood loss =400 mL within 3 months before this study; 7. Smoking more than 5 cigarettes per day within 3 months before this study, or not willing to give up smoking during the trial; 8. More than 25 g of pure alcohol (equivalent to 750 ml of beer or 250 ml of wine or 50 g of liquor) per day on average in the 3 months prior to the study, or be positive for alcohol breath test during the screening or baseline period, or be unwilling to give up drinking during the study period; 9. History of drug abuse within 12 months before the study, or evidence of drug abuse during screening; 10. Positive urine drug results during the screening or at baseline; 11. Positive results of nucleic acid test of neocoronavirus during the screening or at baseline; 12. Participants who have enrolled in any drug clinical trial within 3 months before screening or plan to participate in other clinical trials during the trial; 13. Positive blood pregnancy test/pregnant or lactating women; 14. Unwilling or unable to comply with the lifestyle guidelines in the study protocol; 15. Subjects are the ones of the center or sponsor who are directly involved in the study or their immediate family members (spouse, parent/legal guardian, sibling or children).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC (0-24h) of insulin degludec;AUC (0-t) of insulin aspart;Cmax of insulin aspart; | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC(0-120h), AUC(0-8), AUC(0-12h), AUC(12-24h), Tmax, t1/2 and Cmax of insulin degludec;AUC(0-8), Tmax and t/2 of insulin aspart;Adverse events reported throughout the trial;Hypoglycemia reported throughout the trial;Vital signs;Physical examination;Laboratory test (routine blood parameters, urine routines, and blood biochemical parameters);12-lead electrocardiogram test; | — |
Countries
China
Contacts
Public ContactYerong Yu
West China Hospital, Sichuan University
Outcome results
None listed