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Status unknownNCT05089942Updated Nov 19, 2021

Efficacy and Safety of Recombinant Human Insulin Patch ZJSRM2021

A Phase 4 interventional study of Recombinant Human Insulin Patch ZJSRM2021 and Placebo in type1diabetes and Type2 Diabetes, sponsored by Zhejiang Provincial People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-19.

Sponsored by Zhejiang Provincial People's Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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

02

Conditions studied

  • type1diabetes
  • Type2 Diabetes

Keywords

  • insulin patch
  • type 1 diabetes mellitus
  • type 2 diabetes mellitus
  • safety
  • efficacy
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's planned enrollment of 16 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Zhejiang Provincial People's Hospital is the lead sponsor of 60 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    Recombinant Human Insulin Patch ZJSRM2021

    health subjects or diabetic patients receive recombinant human insulin patch ZJSRM2021

    Drug: Recombinant Human Insulin Patch ZJSRM2021

  • Placebo comparator
    Placebo

    health subjects receive patch

    Drug: Placebo

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

06

What researchers measure

Primary outcomes

  1. Efficacy of Recombinant Human Insulin Patch ZJSRM2021

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

    Time frame: maximum 1 years

Secondary outcomes

  1. 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

    Time frame: maximum 1 years

  2. 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

    Time frame: maximum 1 years

  3. 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

    Time frame: maximum 1 years

07

Study locations

1 site
  • Zhejiang provincial people's hospital
    Hangzhou, Zhejiang 310000, China
08

References and documents

Individual participant data

Plan to share: No — No plan to share data

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05089942
Lead sponsor
Zhejiang Provincial People's Hospital
Responsible party
Xiao Ye, MD (Doctor, Zhejiang Provincial People's Hospital) — Principal investigator
First posted
Oct 22, 2021
Start date
Dec 2021 (estimated)
Primary completion
Dec 2021 (estimated)
Completion
Dec 2022 (estimated)
Last update
Nov 19, 2021

Study contacts

Xiao Ye
Contact
semper_fi@foxmail.com
+8657185893937
Yu Lei
Contact
semper_fi@foxmail.com
+8657185893937
Xiaohong X Wu
principal investigator · Department of Endocriology, Zhejiang Provincial People's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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