| Trial ID: | L6143 |
| Source ID: | NCT05089942
|
| Associated Drug: |
Recombinant Human Insulin Patch Zjsrm2021
|
| Title: |
Efficacy and Safety of Recombinant Human Insulin Patch ZJSRM2021
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
type1diabetes|Type2 Diabetes
|
| Interventions: |
DRUG: Recombinant Human Insulin Patch ZJSRM2021|DRUG: Placebo
|
| Outcome Measures: |
Primary: Efficacy of Recombinant Human Insulin Patch ZJSRM2021, the glucose and insulin level after receiving Recombinant Human Insulin Patch ZJSRM2021, maximum 1 years | Secondary: 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
|
| Sponsor/Collaborators: |
Sponsor: Zhejiang Provincial People's Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
16
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-12
|
| Completion Date: |
2022-12
|
| Results First Posted: |
|
| Last Update Posted: |
2021-11-19
|
| Locations: |
Zhejiang provincial people's hospital, Hangzhou, Zhejiang, 310000, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05089942
|
