diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) The biochemical indicators, blood pressure, ECG and other test results are normal, and the normal subjects without diabetes and other endocrine diseases are determined; (2) Healthy male subjects aged 18-75 (inclusive) with no abnormal and clinically significant vital sign test results, physical examination results, laboratory test results and electrocardiogram results judged by the investigator at the time of screening); (3) Subjects with abnormal glucose tolerance (fasting glucose [FPG]=12g/L during screening; (6) Participants who agree to participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Relevant personnel participating in or carrying out this study; (2) Subjects who have participated in other clinical trials within 3 months or plan to participate in other clinical trials during or within 1 month after the end of the trial; (3) Subjects with severe recurrent hypoglycemia in the past month; Subjects with a history of adverse glycemic control events such as diabetic ketoacidosis or hyperosmolative coma in the past six months; (4) Subjects who had a serious cardiovascular event, such as myocardial infarction, acute coronary syndrome, cerebral infarction, or cardiovascular surgery, within the last 6 months; (5) Subjects using hormones or immunosuppressants with low or defective immunity; (6) Healthy subjects with end-stage renal disease who are undergoing dialysis; (7) Subjects with a history of tumor in the past 5 years; (8) Unstable healthy subjects with major mental disorders; (9) Subjects with long-term alcohol and drug abuse; (10) Subjects with acute or chronic diseases that have skin lesions at the injection site that affect the test results; (11) Healthy subjects who had previously received insulin or insulin preparations subcutaneously; (12) Subjects allergic to insulin or insulin preparations; (13) Healthy subjects with a definite infection, such as pneumonia, within one month; (14) Subjects who are expected to have poor compliance and cannot be treated according to the study protocol; (15) Subjects with a history of hemoglobin disorders (such as thalassemia, sickle cell anemia, etc.) or anemia due to any cause.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| GIR;Skin condition at injection site; | — |
Primary
| Measure | Time frame |
|---|---|
| insulin; | — |
Countries
China
Contacts
Beijing Hospital