Efficacy and Safety of Recombinant Human Insulin Patch ZJSRM2021

Study Overview
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Brief Summary
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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

Official Title
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Efficacy and Safety of Recombinant Human Insulin Patch ZJSRM2021 in Healthy and Diabetic Patients

Conditions
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type1diabetes, Type2 Diabetes

Intervention / Treatment
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* Drug: Recombinant Human Insulin Patch ZJSRM2021
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1or type 2 diabetes Body mass index：19 35kg/m2（include） HbA1c≤11.0% Diabetic duration of T1DM was ≥1 year, and the subjects received insulin injections during the past year .Metformin and glycosidase inhibitors were also allowed. 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: other type diabetes Use of other oral antidiabetics drugs within the 1 months prior to screening. With a history of malignant tumor. With acute or chronic infection. With evidence of major active psychiatric disorders. Drug abuse or alcohol abuse. Drunk too much tea or coffee(more than 2000ml per day). History of any drug allergies. Anti-insulin antibody positive. Participated in clinical trials within 3 months prior to signing the informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recombinant Human Insulin Patch ZJSRM2021<br>health subjects or diabetic patients receive recombinant human insulin patch ZJSRM2021 | Drug: Recombinant Human Insulin Patch ZJSRM2021<br>* health subjects receive recombinant human insulin patch ZJSRM2021，diabetic patients receive recombinant human insulin patch ZJSRM2021（low-dosage or high dosage）<br>|
| Placebo Comparator: Placebo<br>health subjects receive patch | Drug: Placebo<br>* health subjects receive placebo patch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin patch, type 1 diabetes mellitus, type 2 diabetes mellitus, safety, efficacy