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Efficacy and Safety of Recombinant Human Insulin Patch ZJSRM2021

Primary Purpose

type1diabetes, Type2 Diabetes

Status

Not yet recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Recombinant Human Insulin Patch ZJSRM2021

Placebo

About this trial

This is an interventional treatment trial for type1diabetes focused on measuring insulin patch, type 1 diabetes mellitus, type 2 diabetes mellitus, safety, efficacy

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Zhejiang provincial people's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Recombinant Human Insulin Patch ZJSRM2021

Placebo

Arm Description

health subjects or diabetic patients receive recombinant human insulin patch ZJSRM2021

health subjects receive patch

Outcomes

Primary Outcome Measures

Efficacy of Recombinant Human Insulin Patch ZJSRM2021

the glucose and insulin level after receiving Recombinant Human Insulin Patch ZJSRM2021

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT05089942

First Posted

October 20, 2021

Last Updated

November 11, 2021

Sponsor

Zhejiang Provincial People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05089942

Brief Title

Efficacy and Safety of Recombinant Human Insulin Patch ZJSRM2021

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 2021 (Anticipated)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

type1diabetes, Type2 Diabetes

Keywords

insulin patch, type 1 diabetes mellitus, type 2 diabetes mellitus, safety, efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Recombinant Human Insulin Patch ZJSRM2021

Arm Type

Experimental

Arm Description

health subjects or diabetic patients receive recombinant human insulin patch ZJSRM2021

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

health subjects receive patch

Intervention Type

Drug

Intervention Name(s)

Recombinant Human Insulin Patch ZJSRM2021

Intervention Description

health subjects receive recombinant human insulin patch ZJSRM2021，diabetic patients receive recombinant human insulin patch ZJSRM2021（low-dosage or high dosage）

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

health subjects receive placebo patch

Primary Outcome Measure Information:

Title

Efficacy of Recombinant Human Insulin Patch ZJSRM2021

Description

the glucose and insulin level after receiving Recombinant Human Insulin Patch ZJSRM2021

Time Frame

maximum 1 years

Secondary Outcome Measure Information:

Title

Incidence of adverse event of Recombinant Human Insulin Patch ZJSRM2021

Description

Any adverse event(such as tachycardia, hypertension, hypoglycemia，coma) of Recombinant Human Insulin Patch ZJSRM2021

Time Frame

maximum 1 years

Title

Skin irritation assessment and pain assessment of Recombinant Human Insulin Patch ZJSRM2021

Description

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

Time Frame

maximum 1 years

Title

Pain assessment of Recombinant Human Insulin Patch ZJSRM2021

Description

Pain assessment（Visual Analogue Score，VAS，Score range from 0：no pain to 10：most pain） after receiving Recombinant Human Insulin Patch ZJSRM2021

Time Frame

maximum 1 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiao Ye

Phone

+8657185893937

semper_fi@foxmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yu Lei

Phone

+8657185893937

semper_fi@foxmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaohong X Wu

Organizational Affiliation

Department of Endocriology, Zhejiang Provincial People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhejiang provincial people's hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No plan to share data

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Efficacy and Safety of Recombinant Human Insulin Patch ZJSRM2021

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