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Alterations in insulin absorption with varying insulin injection sites by needle-free jet injection in Healthy Chinese Male Subjects.

Alterations in insulin absorption with varying insulin injection sites by needle-free jet injection in Healthy Chinese Male Subjects.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100049569
Enrollment
Unknown
Registered
2021-08-03
Start date
2020-03-01
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes

Interventions

Group A: abdominal injection, group B: upper arm injection, group C: thigh injection:Nil

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 32 Years

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

MeasureTime frame
GIR;Skin condition at injection site;

Primary

MeasureTime frame
insulin;

Countries

China

Contacts

Public ContactPan Qi

Beijing Hospital

panqi621@126.com+86 18901330621

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026