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Efficacy and Safety of Recombinant Human Insulin Patch ZJSRM2021

NCT ID: NCT05089942

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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type1diabetes Type2 Diabetes

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Recombinant Human Insulin Patch ZJSRM2021

health subjects or diabetic patients receive recombinant human insulin patch ZJSRM2021

Group Type EXPERIMENTAL

Recombinant Human Insulin Patch ZJSRM2021

Intervention Type DRUG

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 patch

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

health subjects receive placebo patch

Interventions

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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）

Intervention Type DRUG

Placebo

health subjects receive placebo patch

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhejiang Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiao Ye, MD

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaohong X Wu

Role: PRINCIPAL_INVESTIGATOR

Department of Endocriology, Zhejiang Provincial People's Hospital

Locations

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Zhejiang provincial people's hospital

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Xiao Ye

Role: CONTACT

Phone: +8657185893937

Email: [email protected]

Yu Lei

Role: CONTACT

Phone: +8657185893937

Email: [email protected]

Other Identifiers

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ZJSRM2021

Identifier Type: -

Identifier Source: org_study_id