Table 2 Discontinuation criteria
Participant withdrawal of consent |
Serious violation of study protocol |
Considered inappropriate to continue the trial by investigators due to following conditions: |
  Severe hypoglycemia |
  Development of diabetic ketoacidosis |
  Serious dehydration requiring rehydration therapy |
  Seriously poor glycemic control (HbA1c ≥ 10.0%) |
  Aggravation of primary disease or complications |
  Adverse side effects of the trial drug |
  Other reasons |
Discontinuation of ipragliflozin or use of other SGLT2is in the ipragliflozin group |
Use of SGLT2is in the control group |
Serious violation of study protocol |
Participant withdrawal of consent |