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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
health subjects receive recombinant human insulin patch ZJSRM2021,diabetic patients receive recombinant human insulin patch ZJSRM2021(low-dosage or high dosage)
health subjects receive placebo patch
Zhejiang provincial people's hospital
Hangzhou, Zhejiang, China
Efficacy of Recombinant Human Insulin Patch ZJSRM2021
the glucose and insulin level after receiving Recombinant Human Insulin Patch ZJSRM2021
Time frame: maximum 1 years
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
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
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
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