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 |