Efficacy and Safety of Recombinant Human Insulin Patch ZJSRM2021

Zhejiang Provincial People's Hospital

Status and phase: Unknown; Phase 4

Conditions: Type2 Diabetes; type1diabetes

Treatments: Drug: Placebo; Drug: Recombinant Human Insulin Patch ZJSRM2021

Study type: Interventional

Funder types: Other

Identifiers

NCT05089942

ZJSRM2021

Details and patient eligibility

About

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

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups, including a placebo group

Recombinant Human Insulin Patch ZJSRM2021

Experimental group

Description:

health subjects or diabetic patients receive recombinant human insulin patch ZJSRM2021

Treatment:

Drug: Recombinant Human Insulin Patch ZJSRM2021

Placebo

Placebo Comparator group

Description:

health subjects receive patch

Treatment:

Drug: Placebo