The authors evaluated the change in HbA1c from BL to month 12, central laboratory-measured FPG, prebreakfast SMPG, 8-point SMPG profiles, and insulin dose (basal and mealtime), as well as hypoglycemic events, changes in body weight, AEs, and participant-reported satisfaction with the treatment and perception of the occurrence of hypo- and hyperglycemia [using the DTSQ, health-related quality of life (EQ-5D) utility index score, and hypoglycemia fear survey (HFS II)] [51, 52]. Here, INS is linked to Hypoglycemia.