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The aim of this study is to investigate the efficacy,safety, and tolerability of the recombinant human insulin patch ZJSRM2021 in healthy subjects, type 1diabetes mellitus and type 2diabetes mellitus patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant Human Insulin Patch ZJSRM2021 | Experimental | health subjects or diabetic patients receive recombinant human insulin patch ZJSRM2021 |
|
| Placebo | Placebo Comparator | health subjects receive patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Insulin Patch ZJSRM2021 | Drug | health subjects receive recombinant human insulin patch ZJSRM2021,diabetic patients receive recombinant human insulin patch ZJSRM2021(low-dosage or high dosage) |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Recombinant Human Insulin Patch ZJSRM2021 | the glucose and insulin level after receiving Recombinant Human Insulin Patch ZJSRM2021 | maximum 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse event of Recombinant Human Insulin Patch ZJSRM2021 | Any adverse event(such as tachycardia, hypertension, hypoglycemia,coma) of Recombinant Human Insulin Patch ZJSRM2021 | maximum 1 years |
| Skin irritation assessment and pain assessment of Recombinant Human Insulin Patch ZJSRM2021 |
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Inclusion Criteria:
Newly diagnosed T2DM or metformin-only, and the drug dose remained stable for ≥30 days. Or T2DM patients withdrawed drug ≥30 days of drug after diagnosis.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Ye | Contact | +8657185893937 | semper_fi@foxmail.com | |
| Yu Lei | Contact | +8657185893937 | semper_fi@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaohong X Wu | Department of Endocriology, Zhejiang Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang provincial people's hospital | Hangzhou | Zhejiang | 310000 | China |
No plan to share data
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Drug | health subjects receive placebo patch |
|
Skin irritation assessment(Score range from 0:no irritation to 7:Intense stimulation such as blisters exceeds the patch coverage) after receiving Recombinant Human Insulin Patch ZJSRM2021 |
| maximum 1 years |
| Pain assessment of Recombinant Human Insulin Patch ZJSRM2021 | Pain assessment(Visual Analogue Score,VAS,Score range from 0:no pain to 10:most pain) after receiving Recombinant Human Insulin Patch ZJSRM2021 | maximum 1 years |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |