Table 3.

Discontinuance criteria

Severe hypoglycemia that needs some support by family members or medical care at medical settings

Seriously poor glycemic control such as ≥HbA1c 10.0 %

Diabetic ketoacidosis

Dehydration

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

Offer for participation declined by participants

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