Table 2 Discontinuance criteria

Severe hypoglycemia

Seriously poor glycemic control such as ≥HbA1c 12.0 % confirmed by second measurement on different day

Offer for participation declined by participants

Deviancy of eligibility after registration

Considered inappropriate to continue the study by investigators due to aggravation of primary disease or complications

Considered inappropriate to continue the study by investigators due to adverse side effects of the study drug

Pregnant

Poor drug adherence (<75 %, or >120 %)

Considered inappropriate to continue the study by investigators due to some other reason