During the randomized treatment period, AEs were reported in 71 (87.7%) patients: 36 (94.7%) receiving incretin-based therapy and 35 (81.4%) receiving insulin, most commonly (≥ 10% of patients overall) hypoglycemia (n = 13; 16.0%), cholelithiasis (n = 12; 14.8%), decreased weight (n = 12; 14.8%), diarrhea (n = 10; 12.3%) and nausea (n = 9; 11.1%). Here, INS is linked to cholelithiasis.