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Table 2 Discontinuation criteria

From: Rationale and design of an investigator-initiated, multicenter, prospective open-label, randomized trial to evaluate the effect of ipragliflozin on endothelial dysfunction in type 2 diabetes and chronic kidney disease: the PROCEED trial

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
  1. SGLT2is sodium glucose cotransporter 2 inhibitors