Table 2.

Discontinuation criteria

Severe hypoglycemia

Seriously poor glycemic control (HbA1c ≥10.0%)

Development of diabetic ketoacidosis

Serious dehydration requiring rehydration therapy

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

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

Considered inappropriate to continue the trial by investigators due to some other reasons

Participant withdrawal of consent