Efficacy and Safety of Recombinant Human Insulin Patch ZJSRM2021

Phase 4

• Conditions: type1diabetes; Type2 Diabetes
• Interventions: Drug: Recombinant Human Insulin Patch ZJSRM2021; Drug: Placebo

• Registration Number: NCT05089942
• Lead Sponsor: Zhejiang Provincial People's Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-10-22
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-11
• Last Update Posted: 2021-11-19
• Study Start: 2021-12
• Primary Completion: 2021-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recombinant Human Insulin Patch ZJSRM2021	Recombinant Human Insulin Patch ZJSRM2021	health subjects or diabetic patients receive recombinant human insulin patch ZJSRM2021
Placebo	Placebo	health subjects receive patch

Primary Outcome Measures

Name	Time	Method
Efficacy of Recombinant Human Insulin Patch ZJSRM2021	maximum 1 years	the glucose and insulin level after receiving Recombinant Human Insulin Patch ZJSRM2021

Secondary Outcome Measures

Name	Time	Method
Skin irritation assessment and pain assessment of Recombinant Human Insulin Patch ZJSRM2021	maximum 1 years	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
Incidence of adverse event of Recombinant Human Insulin Patch ZJSRM2021	maximum 1 years	Any adverse event(such as tachycardia, hypertension, hypoglycemia，coma) of Recombinant Human Insulin Patch ZJSRM2021
Pain assessment of Recombinant Human Insulin Patch ZJSRM2021	maximum 1 years	Pain assessment（Visual Analogue Score，VAS，Score range from 0：no pain to 10：most pain） after receiving Recombinant Human Insulin Patch ZJSRM2021

Trial Locations

Locations (1)

Zhejiang provincial people's hospital; 🇨🇳 Hangzhou, Zhejiang, China