Table 1.

Trial designs for PIONEER 3, 4, 5, 7 and 8

	PIONEER 3	PIONEER 4	PIONEER 5	PIONEER 7	PIONEER 8
FAS, N	1864	711	324	504	731
Oral semaglutide dose	3 mg OD 7 mg OD 14 mg OD	14 mg OD	14 mg OD	Flexiblea	3 mg OD 7 mg OD 14 mg OD
Comparator(s)	Sitagliptin 100 mg OD	Liraglutide 1.8 mg OD Placebo	Placebo	Sitagliptin 100 mg OD	Placebo
Randomisation	1:1:1:1	2:2:1	1:1	1:1	1:1:1:1
Duration	78 weeks	52 weeks	26 weeks	52 weeks	52 weeks
Trial design	Double-blind, double-dummy, noninferiority and superiority	Double-blind, double-dummy, noninferiority and superiority	Double-blind, superiority	Open-label, superiority	Double-blind, superiority
Stratification by permitted background medication	Met SU + met	Met SGLT2i + metb	Met SU ± met Ins ± met	1–2 of: Met, SU, SGLT2i, TZD	Basal, premixed or basal-bolus insulin ± met

FAS full analysis set, ins insulin, met metformin, N number of patients included in analyses, OD once daily, RCT randomised controlled trial, SGLT2i sodium-glucose cotransporter-2 inhibitor, SU sulphonylurea, TZD thiazolidinedione

^aDose adjustable according to efficacy and safety criteria and investigator’s clinical judgement

^bShort-term insulin (≤ 14 days) was also permitted but is not part of these subgroup analyses