diabetes
Conditions
Interventions
Case series:novo nordisk company development and production of door winter insulin injection (aspart ) single dose of subcutaneous injection
Sponsors
the First Affiliated Hospital of Bengbu Medical College
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Participate in the experiment voluntarily and sign the informed consent; (2) Medical history of inadvertence, liver, kidney, digestive tract, nervous system diseases and metabolic abnormalities in healthy Chinese adult male subjects aged 18 to 45 years (including 18 and 45 years old); At the time of screening, there were clinically significant vital signs, physical examination, laboratory examination and 12-lead electrocardiogram results as determined by the investigator); (3) Body weight >=50.0kg, body mass index 19.0 to 26.0 kg/m2 (including 19.0 and 26.0 kg/m2); (4) Normal glucose tolerance (3.9mmol/L< fasting glucose < 6.1mmol/L, and glucose < 7.8mmol/L 2 h after oral administration of 75 grams of glucose), normal islet secretion function (the researchers judged by the results of the insulin release test); (5) No family history of diabetes and obesity; (6) Able to communicate well with researchers and complete research according to research regulations.
Exclusion criteria
Exclusion criteria: Any of the following conditions shall not be included in this test: (1) The test results of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody and syphilis are abnormal and of clinical significance; (2) Those who are clearly allergic to insulin or its preparation ingredients; People with drug (including salicylic acid) or food allergy or allergic constitution; (3) Screening for history of hypoglycemia in the first 3 months; (4) Patients who had severe infection or trauma within 4 weeks before screening or who had received hand surgery within 3 months before screening; (5) use of any drug (such as corticosteroids, danazol, dichlorosine, diuretics, epinephrine, salbutamol, terbutaline, glucagon, growth hormone, thyroid hormone, beta-blockers, etc.) that may affect the glucose-lowering effects of insulin during the 4 weeks prior to screening; (6) Those who have special requirements on diet or cannot follow a unified diet; (7) having used any prescription drugs, non-prescription drugs, Chinese herbs and health products (except routine vitamin supplements) within 4 weeks before administration; (8) Present or previous disease history of heart, liver, kidney, digestive tract, nervous system, respiratory system, mental and metabolic abnormalities considered significant by the researchers; (9) If the results of physical examination, vital signs, electrocardiogram and laboratory examination are abnormal and have clinical significance (the judgment of the clinician shall prevail); (10) Subjects who have donated blood within one month before screening, or who have donated blood or lost blood more than 400 mL within three months, or who plan to donate blood or blood components within three months after the study; (11) Heavy smokers (smoking 5 or more cigarettes per day), or those who have been included in the study and cannot be prohibited from smoking throughout the study period; (12) Alcoholics (who drink more than 14 units of alcohol per week :1 unit ˜ 365 beer (13) excessive daily consumption of tea, coffee or caffeinated beverages (more than 8 cups, 1 cup =250 mL), or disapproved consumption of grapefruit juice or any food or beverage containing alcohol and xanthine (including chocolate, tea, coffee, cola, etc.) 48 hours before administration and throughout the study period; (14) Urine tests of illegal drugs (morphine, methamphetamine, ketamine, dimethylene dioxymethamphetamine, tetrahydrocannabinic acid, cocaine) during drug abuse or screening are positive; (15) Patients who have difficulty in vein blood sampling, or cannot tolerate vein puncture, or have a history of fainting needles and blood; (16) those who participated in any clinical trial during the three months preceding the trial, or who plan to participate in other clinical trials during the trial or within one month after the trial; (17) The subject or his/her partner has family planning or is unwilling to use effective contraceptive methods during or within 6 months after the end of the study; Other conditions that the researcher considered inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-10h;Serum midwinter insulin concentration;The drug concentration of c-peptide in serum;GIRmax;GIR-AUC0-10h; | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC0-8;Tmax;t1/2z;?z;tGIRmax; | — |
Countries
China
Contacts
Public ContactZhouhuan
the First Affiliated Hospital of Bengbu Medical College
Outcome results
None listed