TABLE 1.

Summary of the trial designs of PIONEER 1, 3, 4 and 8 ⁸ , ¹⁰ , ¹¹ , ¹⁵

Trial (N)	Treatment arms	Key inclusion criteria	Trial duration	Primary/secondary efficacy endpoint
PIONEER 1 (global: 703; Japan: 116)	Oral semaglutide 3 mg Oral semaglutide 7 mg Oral semaglutide 14 mg Placebo	Receiving diet and exercise therapy HbA1c 7.0% to 9.5% (53 mmol/mol to 80 mmol/mol)	26 weeks	Change in HbA1c from baseline to week 26 Change in body weight from baseline to week 26
PIONEER 3 (global: 1864; Japan: 207)	Oral semaglutide 3 mg Oral semaglutide 7 mg Oral semaglutide 14 mg Sitagliptin 100 mg	Treated with metformin ± SU HbA1c 7.0% to 10.5% (53 mmol/mol to 91 mmol/mol)	78 weeks	Change in HbA1c from baseline to week 26 Change in body weight from baseline to week 26
PIONEER 4 (global: 711; Japan: 75)	Oral semaglutide 14 mg Liraglutide 1.8 mg s.c. Placebo	Treated with metformin ± SGLT2i HbA1c 7.0% to 9.5% (53 mmol/mol to 80 mmol/mol)	52 weeks	Change in HbA1c from baseline to week 26 Change in body weight from baseline to week 26
PIONEER 8 (global: 731; Japan: 194)	Oral semaglutide 3 mg Oral semaglutide 7 mg Oral semaglutide 14 mg Placebo	Treated with insulin a ± metformin HbA1c 7.0% to 9.5% (53 mmol/mol to 80 mmol/mol)	52 weeks	Change in HbA1c from baseline to week 26 Change in body weight from baseline to week 26

Abbreviations: HbA1c, glycated haemoglobin; N, number of randomized patients in the specified patient population; s.c., subcutaneous; SGLT2i, sodium‐glucose cotransporter‐2 inhibitor; SU, sulphonylurea.

^aBasal, basal‐bolus or premixed insulin.