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Table 3 Summary of safety data across the PIONEER trials

From: Advances in GLP-1 treatment: focus on oral semaglutide

Trial Treatment (n) Adverse events (n) Discontinuation due to adverse events % (n) Severe hypoglycemia episodesb % (n)
Total % (n) Seriousa % (n)
PIONEER 1 Sema 3 mg (175) 57.7 (101) 2.9 (5) 2.3 (4) 0
Sema 7 mg (175) 53.1 (93) 1.7 (3) 4.0 (7) 0.6 (1)
Sema 14 mg (175) 56.6 (99) 1.1 (2) 7.4 (13) 0
Pbo (178) 56.6 (99) 4.5 (8) 2.2 (4) 0
PIONEER 2 Sema 14 mg (410) 70.5 (289) 6.6 (27) 10.7 (44) 1.7 (7)
Empa 25 mg (409) 69.2 (283) 9.0 (37) 4.4 (18) 2.0 (8)
PIONEER 3 Sema 3 mg (466) 79.4 (370) 13.7 (64) 5.6 (26) 4.9 (23)
Sema 7 mg (464) 78.2 (363) 10.1 (47) 5.8 (27) 5.2 (24)
Sema 14 mg (465) 79.6 (370) 9.5 (44) 11.6 (54) 7.7 (36)
Sita 100 mg (466) 83.3 (388) 12.4 (58) 5.2 (24) 8.4 (39)
PIONEER 4 Sema 14 mg (285) 80.0 (229) 11.0 (31) 11.0 (31) 1.0 (2)
Lira 1.8 mg (284) 74.0 (211) 8.0 (22) 9.0 (26) 2.0 (7)
Pbo (142) 67.0 (95) 11.0 (15) 4.0 (5) 2.0 (3)
PIONEER 5 Sema 14 mg (163) 75.0 (122) 12.0 (20) 15.0 (24) 6.0 (9)
Pbo (161) 68.0 (109) 11.0 (18) 5.0 (8) 2.0 (3)
PIONEER 6 Sema 14 mg (1591) 18.9 (301) 11.6 (184) 1.4 (23)
Pbo (1592) 22.5 (358) 6.5 (104) 0.8 (13)
PIONEER 7 Sema Flex (253) 78.0 (197) 9.0 (24) 9.0 (22) 0
Sita 100 mg (250) 69.0 (172) 10.0 (24) 3.0 (8) 0
PIONEER 8 Sema 3 mg (184) 74.5 (137) 13.6 (25) 7.1 (13) 28.3 (52)
Sema 7 mg (181) 78.5 (142) 10.5 (19) 8.8 (16) 26.0 (47)
Sema 14 mg (181) 83.4 (151) 6.6 (12) 13.3 (24) 26.5 (48)
Pbo (184) 75.5 (139) 9.2 (17) 2.7 (5) 29.3 (54)
  1. Dula dulaglutide; Empa empagliflozin; Flex flexible dose adjustment; GI gastrointestinal; Lira liraglutide; N number; Pbo placebo; Sema oral semaglutide; Sita sitagliptin
  2. aSerious adverse events are based on patient/event outcome or action criteria usually associated with events that pose a threat to the patient’s life or functioning
  3. bHypoglycemic episodes were considered severe and defined as blood glucose lower than 56 mg/dL (< 3.1 mmol/L) associated with symptoms consistent with hypoglycemia (defined according to the American Diabetes Association classification)