Efficacy and Safety of Recombinant Human Insulin Patch ZJSRM2021

NCT05089942 | Unknown Phase 4

• 1 other identifier: ZJSRM2021
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

type1diabetes; Type2 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Efficacy of Recombinant Human Insulin Patch ZJSRM2021

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

  maximum 1 years

Secondary Outcomes (3)

• Incidence of adverse event of Recombinant Human Insulin Patch ZJSRM2021

  maximum 1 years

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

  maximum 1 years

• Pain assessment of Recombinant Human Insulin Patch ZJSRM2021

  maximum 1 years

Study Arms (2)

Recombinant Human Insulin Patch ZJSRM2021

EXPERIMENTAL

health subjects or diabetic patients receive recombinant human insulin patch ZJSRM2021

Drug: Recombinant Human Insulin Patch ZJSRM2021

Placebo

PLACEBO COMPARATOR

health subjects receive patch

Drug: Placebo

Interventions

Recombinant Human Insulin Patch ZJSRM2021 DRUG

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

Recombinant Human Insulin Patch ZJSRM2021

Placebo DRUG

health subjects receive placebo patch

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

Study Sites (1)

Zhejiang provincial people's hospital

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Xiaohong X Wu

  Department of Endocriology, Zhejiang Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao Ye

CONTACT

+8657185893937; semper_fi@foxmail.com

Yu Lei

CONTACT

+8657185893937; semper_fi@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: October 22, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)