Table 4

Summary of PIONEER safety outcomes28 30–38

Trial (number of participants)	Doses and comparators	Duration in weeks	AE (%)	Discontinuation due to AE (%)	Discontinuation due to GI AE (%)	Severe or BG-confirmed hypoglycemia (%)
PIONEER 1 (n=703)23	Oral semaglutide 3 mg	26	58	2	2	3
	Oral semaglutide 7 mg		53	4	2	1
	Oral semaglutide 14 mg		57	7	5	1
	Placebo		56	2	1	1
PIONEER 2 (n=822)20	Oral semaglutide 14 mg	52	70	11	8	2
PIONEER 2 (n=822)20	Empagliflozin 25 mg		69	4	1	2
PIONEER 3 (n=1864)22	Oral semaglutide 3 mg	78	79	6	2	5
	Oral semaglutide 7 mg		78	6	3	5
	Oral semaglutide 14 mg		80	12	7	8
	Sitagliptin 100 mg		83	5	3	8
PIONEER 4 (n=711)²⁵	Oral semaglutide 14 mg	52	80	11	8	1
	Liraglutide 1.8 mg		74	9	6	2
	Placebo		67	4	2	2
PIONEER 5 (n=324)24	Oral semaglutide 14 mg	26	74	15	12	6
PIONEER 5 (n=324)24	Placebo		65	5	2	2
PIONEER 6 (n=3183)30	Oral semaglutide 14 mg	*	NR	12	7	NR
PIONEER 6 (n=3183)30	Placebo			7	2
PIONEER 7 (n=504)28	Oral semaglutide (flexible dose 3, 7, or 14 mg)	52	78	9	6	6
PIONEER 7 (n=504)28	Sitagliptin 100 mg		69	3	1	6
PIONEER 8 (n=731)27	Oral semaglutide 3 mg	52	74	7	5	28
	Oral semaglutide 7 mg		78	9	7	26
	Oral semaglutide 14 mg		83	13	10	27
	Placebo		76	3	1	29
PIONEER 9 (n=243)26	Oral semaglutide 3 mg	52	76	2	2	0
	Oral semaglutide 7 mg		76	4	2	0
	Oral semaglutide 14 mg		71	0	4	0
	Liraglutide 0.9 mg		67	0	0	4
	Placebo		80	0	0	0
PIONEER 10 (n=458)29 (n=458) ²⁹	Oral semaglutide 3 mg	52	77	3	31	2
	Oral semaglutide 7 mg		80	6	39	2
	Oral semaglutide 14 mg		85	6	54	3
	Dulaglutide 0.75 mg		82	3	40	0

NR means the value was not recorded in the trial results.
*Ongoing study.
AE, adverse events; BG, blood glucose; GI, gastrointestinal; PIONEER, Peptide Innovation for Early Diabetes Treatment.