Efficacy and Safety of Recombinant Human Insulin Patch ZJSRM2021

Sponsor

Zhejiang Provincial People's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05089942

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
type1diabetes Type2 Diabetes	Drug: Recombinant Human Insulin Patch ZJSRM2021 Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Recombinant Human Insulin Patch ZJSRM2021 health subjects or diabetic patients receive recombinant human insulin patch ZJSRM2021	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 Comparator: Placebo health subjects receive patch	Drug: Placebo health subjects receive placebo patch

Arm

Intervention/Treatment

Experimental: Recombinant Human Insulin Patch ZJSRM2021

health subjects or diabetic patients receive recombinant human insulin patch ZJSRM2021

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 Comparator: Placebo

health subjects receive patch

Drug: Placebo

health subjects receive placebo patch

Outcome Measures

Primary Outcome Measures

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

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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.