Diabetes Mellitus
Conditions
Interventions
Group 2:Phase I: TRESIBA produced from Novo Nordisk
Phase II: Insulin Degludec Injection
Group 1:Phase I: Insulin Degludec Injection
Phase II: TRESIBA produced from Novo Nordisk
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The healthy subjects aged between 18 and 45 years old (including the boundary); 2. During screening period, the researcher assesses the normal or abnormal results, with clinical meaning or without clinical meaning, on vital signs, physical, laboratory examination and electrocardiogram; 3. Male body weight is over 50kg, female body weight is over 45kg, and body mass index (BMI) is between 19.0 and 25.0kg /m2 (including boundary value); 4. The researcher assesses if the abdominal skin of the drug injects is normal, if without fatty hyperplasia, skin sag, skin induration, scar, inflammation, edema, ulcer, infection and bleeding happens; 5. Fasting venous glucose >=3.9mmol/L and < 6.1mmol/L; Glucose tolerance test (OGTT) blood glucose value < 7.8mmol/L after two hours while 75 grams of glucose was taken orally. The insulin release test (IRT) determine that insulin secretion was functioning normally. And, the HbA1c < 6.5%; 6. To voluntarily agree to take effective contraceptive methods within 3 months started when the signing of the informed consent to the last the treatment drug; 7. When it comes to subjects, it would be totally understand comply with the study procedures, voluntarily participate in and sign the informed consent.
Exclusion criteria
Exclusion criteria: 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 atopic allergic disease, or is known to be allergic to treatment drugs or their excipients or similar drugs; 3. Family history of diabetes (first-degree relatives, i.e. parents or siblings); 4. History of severe hypoglycemia attack; 5. A history of hypokalemia; 6. With orthostatic hypotension, syncope or history of amaurosis; 7. Any clinically significant 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 the subject to participate in the study, or not suitable to participate in the study; 8. Has taken any prescription drug within 4 weeks before or within 5 half-lives (prevailed as the older one), taken any over-the-counter drug, chinese medicine or herbal medicine, health care products (except nutritional supplements such as vitamins) within 2 weeks before this study. And, received any vaccination within 4 weeks before administration; 9. Blood donation or blood loss >=400mL within 3 months before this study; 10. Smoking more than 5 cigarettes per day in the 3 months before this study, or not willing to give up smoking during the trial; 11. 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; 12. History of drug abuse within 12 months before the study, or evidence of drug abuse during screening; 13. Positive urine drug results during the screening or baseline period; 14. Have enrolled in any drug clinical trial within 3 months when screening or plan to participate in other clinical trials during the trial; 15. Positive blood pregnancy test/pregnant or lactating women; 16. Unwilling or unable to comply with the lifestyle guidelines in the research; 17. 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 |
|---|---|
| Insulin degludec PK;GIR-AUC (0-24 h); | — |
Countries
China
Contacts
Public ContactYu Yerong
West China Hospital, Sichuan University
Outcome results
None listed