diabetes
Conditions
Interventions
Group A:hyperglycemic clamp
Group B-1:euglycemic clamp after subcutaneous injection of degu insulin 0.2u/kg
Group B-2:euglycemic clamp after subcutaneous injection of degu insulin 0.4u/kg
Group B-3:euglycemic clamp after subcutaneous injection of degu insulin 0.6u/kg
Sponsors
Shanghai Xuhui Central Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Willing to participate in the study, sign ICF, and follow the study procedure according to protocol; 2. Healthy male subjects aged 18-45(included) at the time of signing ICF; 3. Body weight >= 50 kg, and body mass index (BMI) between 19 and 26 kg/m2(included); 4. Upon medical inquiry, no medical history of heart, liver, kidney, digestive tract, nervous system diseases and metabolic abnormalities; 5. Normal vital signs, physical examination, results of laboratory tests and/or ECG, chest radiography, or abnormality with no clinical significance; 6. Normal glucose tolerance [3.9 mmol/L (70 mg/dL)< fasting glucose (FPG)<6.1 mmol/L (110 mg/dL), and 2-hour postprandial glucose <7.8 mmol/L (140 mg/dL)]; 7. Normal insulin secretion (confirmed by insulin releasing test (IRT)); 8. HbA1c less than 6.0% 9. Good venous conditions for establishing blood collection channels according to the study protocol; 10. No birth and sperm donor plan during the study period, willing to use effective contraceptive measures during the study and within 3 months after administration of investigational product.
Exclusion criteria
Exclusion criteria: 1. A history of hypoglycemia within 3 months before screening; 2. Taking any prescription medicine, Chinese herbal medicine, OTC medicine (except paracetamol used occasionally and sparingly), or health care products (except routine vitamin supplement) within 4 weeks before administration; 3. Positive results of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody; 4. History of any malignancy; 5. Participation in any drug or device clinical study within 3 months before administration; 6. Blood donation >= 400 mL within 3 months before administration, or blood loss >= 400 mL due to any reason; 7. Allergy to investigational product or any excipient; 8. Frequent drinkers within 3 months before administration, who drink more than 21 units of alcohol per week (1 unit =360 mL beer or 45 mL spirits with a 40% alcohol content or 150 mL wine), or positive alcohol test; 9. Positive urine drug abuse screening; 10. Smoking more than 10 cigarettes per day within 3 months before administration, or unwilling to comply with the smoking prohibition during the study period; 11. Having any other condition that study doctors consider inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood glucose; | — |
Countries
China
Contacts
Public ContactChen Yu
Shanghai Xuhui Central Hospital
Outcome results
None listed