Efficacy and Safety of Recombinant Human Insulin Patch ZJSRM2021

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Type2 Diabetes; type1diabetes
• Intervention / Treatment: Drug: Recombinant Human Insulin Patch ZJSRM2021; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiao Ye; Phone Number: +8657185893937; Email: semper_fi@foxmail.com
• Study Contact Backup: Name: Yu Lei; Phone Number: +8657185893937; Email: semper_fi@foxmail.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Zhejiang Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 62 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse event of Recombinant Human Insulin Patch ZJSRM2021	Any adverse event(such as tachycardia, hypertension, hypoglycemia，coma) of Recombinant Human Insulin Patch ZJSRM2021	maximum 1 years
Skin irritation assessment and pain assessment of Recombinant Human Insulin Patch ZJSRM2021	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	maximum 1 years
Pain assessment of Recombinant Human Insulin Patch ZJSRM2021	Pain assessment（Visual Analogue Score，VAS，Score range from 0：no pain to 10：most pain） after receiving Recombinant Human Insulin Patch ZJSRM2021	maximum 1 years

Collaborators and Investigators

• Sponsor: Zhejiang Provincial People's Hospital
• Investigators: Principal Investigator: Xiaohong X Wu, Department of Endocriology, Zhejiang Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: safety; efficacy; type 2 diabetes mellitus; type 1 diabetes mellitus; insulin patch
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: ZJSRM2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to share data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No