For the treatment of adult type 2 diabetes
Conditions
Interventions
TR Group:Test formulation - washout period - reference formulation
RT Group:Reference formulation - washout period - test formulation
Sponsors
The Second Affiliated Hospital of Xingtai Medical College
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Volunteer to participate in the experiment and sign the informed consent form. 2. Healthy males in China, aged 18-45 years (inclusive). 3. Body mass index (BMI) is in the range of 19.0-24.0kg/m^2 (inclusive); Weight =50kg. 4. Glucose tolerance test (OGTT)0h intravenous glucose 3.9 mmol/L; OGTT 2h blood sugar value < 7.8 mmol/L; The results of insulin release test (IRT) were judged to be normal by researchers. sugar Hemoglobin < 6.0%. 5. There are no clinically significant heart, liver, kidney, digestive tract, nervous system, respiratory system,Past and/or present medical history such as mental abnormality and metabolic abnormality; Vital signs, physical examination, electrocardiogram, real The results of laboratory examination and chest radiograph are normal or abnormal and have no clinical significance (judged by clinicians,Subject). 6. Agree to use effective methods within 1 month from the signing of the informed consent form to the last administration of the experimental drug. Take contraception and avoid donating sperm during this period. 7. The researcher judged that the skin on the abdominal wall of the drug to be injected was normal, and there was no fat hyperplasia, skin depression,Skin induration, scar, inflammation, edema, ulcer, infection, bleeding, etc. may affect the injection of the subject.The situation of experimental drugs. 8. Be able to communicate well with researchers and complete the experiment according to the experimental regulations.
Exclusion criteria
Exclusion criteria: 1. Have a history of diabetes or first-degree relatives have a history of diabetes. 2. Have a history of hypokalemia, postural hypotension, syncope, blackness or severe hypoglycemia. 3. According to the researcher's judgment, there is a possibility that it may affect the absorption, distribution, metabolism, excretion or safety evaluation of drugs.The compliance can be reduced, or the researcher thinks that there is a safety risk for the subject to participate in the experiment. 4. Those who have a history of acute or chronic respiratory diseases with poor control within 6 months before screening, including but not limited to.Yu: Chronic obstructive pulmonary disease (COPD), severe asthma, severe pneumonia and active tuberculosis. 5. Have performed any major surgery within 6 months before screening or plan to have elective surgery within 1 month after administration. Major surgery is defined as aiming at intracranial, thoracic, abdominal, pelvic or limb organs, resulting in major tissue.Trauma, surgery that requires long-term recovery. 6. Donate blood (including blood component) or lose more than 200mL within 3 months before screening, or receive blood transfusion or use. Blood products. 7. Have a history of severe atopic allergic diseases, or be known to be interested in experimental drugs or their accessories or insulin and Allergic to its analogues. 8. Participated in clinical trials of any approved or unapproved research drugs/devices within 90 days before screening. Test, or plan to participate in other clinical trials during the trial or within 3 months after the trial. 9. It has clinical significance that the detection results of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody or Treponema pallidum specific antibody are abnormal during the screening period. 10. Have a history of drug abuse or a positive urine test for illegal drugs within 12 months before screening. 11. Regular drinking within 6 months before screening (drinking more than 14 units of alcohol per week, 1 unit of about 360mL beer) Wine or 45mL of 40% spirits or 150mL of wine); Or random alcohol breath test Test positive, or unwilling to give up drinking during the trial; 12. Smoking more than 5 cigarettes a day on average within 3 months before screening, or unwilling to give up smoking during the trial. 13. Have used any prescription drugs, traditional Chinese medicines, Chinese herbal medicines or over-the-counter drugs within 4 weeks before administration (if necessary,Paracetamol/paracetamol is allowed, and the maximum allowable dose is 2 g/ day, and it must be recorded in eCRF. ), health care products (except routine vitamin supplements), or received any vaccine within 4 weeks before administration.Kind. 14. Drink too much tea, coffee or caffeinated drinks every day within 2 weeks before administration (=8 cups, 1 cup =250mL).Or do not agree to ban grapefruit juice or any alcohol and alcohol for 48 hours before administration and during the whole experiment.Xanthine (including chocolate, tea, coffee, cola, etc.) foods and drinks. 15. Unwilling or unable to follow the lifestyle guidance described in the experimental scheme. 16. Can't tolerate venipuncture, difficulty in blood collection, history of needle fainting and blood fainting, or can't establish venous access of both upper limbs. 17. The subjects are the people directly involved in this experiment by the research center or the applicant o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degu insulin:Area under the plasma concentration-time curve from 0 to 24 hours;Degu insulin: Area under the plasma concentration-time curve from 0 to 8;Insulin aspart:Area under the plasma concentration-time curve from 0 to 12 hours;Insulin aspart:Area under the plasma concentration-time curve from 0 to 8;Insulin aspart:Peak concentration;Area under the time curve of glucose infusion rate from 0 to 24h;Maximum glucose infusion rate;Area under the time curve of glucose infusion rate from 0 to 2h; | — |
Secondary
| Measure | Time frame |
|---|---|
| Degu insulin:Area under the plasma concentration-time curve from 0 to 12 hours;Degu insulin:Area under the plasma concentration-time curve from 12to 24 hours;Degu insulin:Peak concentration;Degu insulin:half life of elimination;Degu insulin:Peak time;Insulin aspart:Area under the plasma concentration-time curve from 0to 2 hours;Insulin aspart:Area under the plasma concentration-time curve from 0to 6 hours;Insulin aspart:half life of elimination;Insulin aspart:half life of elimination;Area under the time curve of glucose infusion rate from 0 to 6h;Area under the time curve of glucose infusion rate from 0 to 12h;Area under the time curve of glucose infusion rate from 012to 24h;Peak time of glucose infusion rate;Hypoglycemia event;Vital signs, physical examination and 12-lead electrocardiogram;Laboratory examination (blood routine, blood biochemistry, coagulation function and urine routine, etc.);;Injection site reaction;;Adverse events or serious adverse events occurred during treatment;;Immunogenicity evaluation index: the positive rate of anti-insulin deglutinin antibody and anti-insulin aspart antibody (ADA).; | — |
Countries
CHINA
Contacts
Public ContactGou Fengxue
The Second Affiliated Hospital of Xingtai Medical College
Outcome results
None listed