Efficacy and Safety of Recombinant Human Insulin Patch ZJSRM2021

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05089942
• Other study ID #: ZJSRM2021
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 2021
• Est. completion date: December 2022

Study information

• Verified date: November 2021
• Source: Zhejiang Provincial People's Hospital
• Contact: Xiao Ye
• Phone: +8657185893937
• Email: semper_fi[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• type1diabetes
• Type2 Diabetes

Intervention

Drug:
• Recombinant Human Insulin Patch ZJSRM2021
health subjects receive recombinant human insulin patch ZJSRM2021,diabetic patients receive recombinant human insulin patch ZJSRM2021(low-dosage or high dosage)
• Placebo
health subjects receive placebo patch

Locations

Country	Name	City	State
China	Zhejiang provincial people's hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Recombinant Human Insulin Patch ZJSRM2021	the glucose and insulin level after receiving Recombinant Human Insulin Patch ZJSRM2021	maximum 1 years
Secondary	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
Secondary	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
Secondary	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