Efficacy and Safety of Recombinant Human Insulin Patch ZJSRM2021

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05089942

Enrollment

Registered

2021-10-22

Start date

2021-12-31

Completion date

2022-12-31

Last updated

2021-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type1diabetes, Type2 Diabetes

Keywords

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

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

Interventions

DRUGRecombinant 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）

DRUGPlacebo

health subjects receive placebo patch

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactXiao Ye

semper_fi@foxmail.com+8657185893937

Backup ContactYu Lei