type1diabetesPhase 4NCT05089942
Efficacy and Safety of Recombinant Human Insulin Patch ZJSRM2021
A Phase 4 study testing Recombinant Human Insulin Patch ZJSRM2021 in people with type1diabetes and Type2 Diabetes, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- type1diabetes, Type2 Diabetes
- What is being tested?
- Recombinant Human Insulin Patch ZJSRM2021
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- Dec 2021to Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- type1diabetes, Type2 Diabetes
- Being tested
- Recombinant Human Insulin Patch ZJSRM2021, Placebo
- Keywords
- insulin patch, type 1 diabetes mellitus, type 2 diabetes mellitus, safety, efficacy
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Insulin Patch ZJSRM2021Drug
health subjects receive recombinant human insulin patch ZJSRM2021，diabetic patients receive recombinant human insulin patch ZJSRM2021（low-dosage or high dosage）
PlaceboDrug
health subjects receive placebo patch
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Human Insulin Patch ZJSRM2021 | Experimental | health subjects or diabetic patients receive recombinant human insulin patch ZJSRM2021 Receives: Drug: Recombinant Human Insulin Patch ZJSRM2021 |
| Placebo | Placebo comparator | health subjects receive patch Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Recombinant Human Insulin Patch ZJSRM2021
the glucose and insulin level after receiving Recombinant Human Insulin Patch ZJSRM2021
Measured: maximum 1 years
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: maximum 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study startDec 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Ye, MD, Zhejiang Provincial People's Hospital
- Investigators
- Xiaohong X Wu, Principal investigator, Department of Endocriology, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089942
- Sponsor's protocol ID
- ZJSRM2021
- Status last verified
- Nov 2021
- First submitted
- 20 Oct 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Recombinant Human Insulin Patch ZJSRM2021 in Healthy and Diabetic Patients
- ClinicalTrials.gov ID
- NCT05089942
- Acronym / sponsor ID
- ZJSRM2021
- Conditions
- type1diabetes, Type2 Diabetes
- Keywords
- insulin patch, type 1 diabetes mellitus, type 2 diabetes mellitus, safety, efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant Human Insulin Patch ZJSRM2021 | Experimental | Drug: Recombinant Human Insulin Patch ZJSRM2021health subjects or diabetic patients receive recombinant human insulin patch ZJSRM2021 |
| Placebo | Placebo comparator | Drug: Placebohealth subjects receive patch |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Human Insulin Patch ZJSRM2021health subjects receive recombinant human insulin patch ZJSRM2021，diabetic patients receive recombinant human insulin patch ZJSRM2021（low-dosage or high dosage） | Drug | Recombinant Human Insulin Patch ZJSRM2021 |
| Placebohealth subjects receive placebo patch | Drug | Placebo |
Primary outcome
Efficacy of Recombinant Human Insulin Patch ZJSRM2021
Time frame: maximum 1 years
the glucose and insulin level after receiving Recombinant Human Insulin Patch ZJSRM2021
3 secondary outcomes
Incidence of adverse event of Recombinant Human Insulin Patch ZJSRM2021
Time frame: maximum 1 years
Skin irritation assessment and pain assessment of Recombinant Human Insulin Patch ZJSRM2021
Time frame: maximum 1 years
Pain assessment of Recombinant Human Insulin Patch ZJSRM2021
Time frame: maximum 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Individual participant dataSharing planned: No. No plan to share data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaohong X Wu principal investigator
Department of Endocriology, Zhejiang Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Recombinant Human Insulin Patch ZJSRM2021 in people with type1diabetes and Type2 Diabetes, run by Zhejiang Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao Ye (+8657185893937, semper_fi@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Recombinant Human Insulin Patch ZJSRM2021 (time frame: maximum 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.