Screening* Visit 1 | Baseline Visit 2 | Visit 3 | Visit 4 | Follow up (Visit 5) | |
---|---|---|---|---|---|
D-21 ~D-1 | D0 Week 0 | D21 Week 3 | D42 Week 6 | D56 Week 8 | |
Informed consent form | ● | ||||
Demographic information taking 1 | ● | ||||
Medical history taking | ● | ||||
Finger-prick blood glucose testing | ● | ||||
QSCC II 2 | ● | ||||
Inclusion/exclusion criteria check | ● | ||||
Physical examination 3 | ● | ● | ● | ● | |
Vital sign measurement 4 | ● | ● | ● | ● | |
Laboratory test 5 | ● | ● | ● | ● | |
VAS 6 | ● | ● | ● | ● | |
Electrocardiogram(ECG) | ● | ● | |||
Concomitant drugs check | ● | ● | ● | ● | |
Treating physician examination 7 | ● | ● | ● | ● | |
Adverse event monitoring | ● | ● | ● | ||
Compliance checking | ● | ||||
Study drug distribution | ● | ● | |||
Smoking, drinking, coffee taking status 8 | ● | ||||
Diet, physical exercise Counseling 8 | ● | ● |