Table 1.

Key Phase 3 trials of QW GLP‐1 RAs included in this review

Trial name	Study design	Treatment interventions	Study duration	Primary endpoint	Permitted concomitant treatments
DURATION‐1 16	Randomized, comparator‐controlled, open‐label	Exenatide ER	52 weeks	Change from baseline in HbA1c at Week 52	SU
DURATION‐2 70	Randomized, double‐blind	Exenatide ER, sitagliptin, pioglitazone	26 weeks	Change from baseline in HbA1c at Week 26	Metformin, ± SU
DURATION‐3 79	Randomized, open‐label	Exenatide ER	26 weeks	Change from baseline in HbA1c at Week 26	Metformin, ± SU
DURATION‐4 31	Randomized, double‐blind	Exenatide ER, metformin, pioglitazone, sitagliptin	26 weeks	Change from baseline in HbA1c at Week 26	None
DURATION‐5 37	Randomized, open‐label, comparator‐controlled	Exenatide ER, exenatide (BID)	24 weeks	Change from baseline in HbA1c at Week 24	Metformin, SU, TZD, or a combination of these
DURATION‐6 38	Open‐label, randomized, parallel group	Exenatide ER, liraglutide (QD)	26 weeks	Change from baseline in HbA1c at Week 26	Metformin, SU, metformin + SU, or metformin + pioglitazone
DURATION‐7 27	Randomized, double‐blind, parallel group, placebo‐controlled	Exenatide ER, placebo	28 weeks	Change from baseline HbA1c at Week 28	Insulin glargine ± (metformin ± SU)
DURATION‐8 59	Randomized, double‐blind, active‐controlled	Exenatide ER, dapagliflozin, exenatide ER + dapagliflozin	28 weeks	Change from baseline in HbA1c at Week 28	Metformin
DURATION‐NEO‐2 26	Randomized, open‐label, active‐ and placebo‐controlled	Exenatide ER AI, sitagliptin, placebo	28 weeks	Change from baseline in HbA1c at Week 28	Metformin
EXSCEL 28	Randomized, double‐blind, placebo‐controlled	Exenatide ER, placebo	Event driven (median follow‐up 3.2 years)	First occurrence of MACE in a time‐to‐event analysis	≤3 OADs, or ≤2 OADS + insulin
AWARD‐1 15	Randomized, blinded, parallel group and placebo‐controlled	Dulaglutide, exenatide, placebo	52 weeks	Change from baseline in HbA1c at Week 26	Pioglitazone and metformin
AWARD‐2 78	Randomized, open‐label (double‐blind to dulaglutide dose), comparator‐controlled	Dulaglutide, insulin glargine	78 weeks	Change from baseline in HbA1c at Week 52	Metformin and glimepiride
AWARD‐3 30	Randomized, double‐blind, double‐dummy, parallel group	Dulaglutide, metformin	52 weeks	Change from baseline in HbA1c at Week 26	None
AWARD‐4 50	Randomized, open‐label	Dulaglutide, insulin glargine	52 weeks	Change from baseline in HbA1c at Week 26	Insulin lispro, with or without metformin
AWARD‐5 69	Randomized, double‐blind, adaptive, parallel group	Dulaglutide, sitagliptin	52 weeks	Change from baseline in HbA1c at Week 52	Metformin
AWARD‐6 36	Randomized, open‐label	Dulaglutide, liraglutide	26 weeks	Change from baseline in HbA1c at Week 26	Metformin
AWARD‐7 9	Open‐label, randomized, parallel group	Dulaglutide, insulin glargine	52 weeks	Change from baseline in HbA1c at Week 26	Insulin lispro
AWARD‐8 24	Randomized, double‐blind, placebo‐controlled, parallel group	Dulaglutide, placebo	24 weeks	Change from baseline in HbA1c at Week 24	Glimepiride
AWARD‐9 25	Randomized, double‐blind, placebo‐controlled, parallel group	Dulaglutide, placebo	28 weeks	Change from baseline in HbA1c at Week 28	Insulin glargine ± metformin
AWARD‐10 54	Randomized, double‐blind, placebo‐controlled, parallel group	Dulaglutide, placebo	24 weeks	Change from baseline in HbA1c at Week 24	SGLT2is ± metformin
REWIND 7	Randomized, double‐blind, placebo‐controlled	Dulaglutide, placebo	Event driven, follow‐up of up to 8 years (median follow‐up 5.4 years)	First occurrence of MACE	Antihyperglycaemic therapies excluding DPP4is or GLP‐1 RAs
SUSTAIN 1 8	Randomized, double‐blind, parallel group	Semaglutide s.c., placebo	30 weeks	Change from baseline in HbA1c at Week 30	Metformin, OADs excluding GLP‐1 RAs or DDP4is
SUSTAIN 2 71	Randomized, double‐blind, double‐dummy, active‐controlled, parallel group	Semaglutide s.c., sitagliptin	56 weeks	Change from baseline in HbA1c at Week 56	Metformin, TZDs, Metformin + TZDs
SUSTAIN 3 39	Randomized, open‐label, active comparator‐controlled, parallel group	Semaglutide s.c., exenatide ER	56 weeks	Change from baseline in HbA1c at Week 56	Metformin ± TZDs/SUs
SUSTAIN 4 80	Randomized, open‐label, active‐controlled, parallel group	Semaglutide s.c., insulin glargine	30 weeks	Change from baseline in HbA1c at Week 30	Metformin, SU
SUSTAIN 5 29	Randomized, double‐blind, placebo‐controlled, parallel group	Semaglutide s.c., placebo	30 weeks	Change from baseline in HbA1c at Week 30	Basal insulin ± metformin
SUSTAIN 6 6	Randomized, double‐blind, placebo‐controlled, parallel group	Semaglutide s.c., placebo	Event driven, Median follow‐up of 2.1 years	First occurrence of MACE over 2.1 years	≤2 OADs ± basal or premixed insulin (no incretin‐based medications were allowed)
SUSTAIN 7 40	Randomized, open‐label, active‐controlled, parallel group	Semaglutide s.c., dulaglutide	40 weeks	Change from baseline in HbA1c at Week 40	Metformin
SUSTAIN 8	Randomized, double‐blind comparator‐controlled parallel group	Semaglutide s.c., canagliflozin	52 weeks	Change from baseline in HbA1c at Week 52	Metformin
SUSTAIN 9 55	Randomized, placebo‐controlled, double‐blind, parallel group	Semaglutide s.c., placebo	30 weeks	Change from baseline in HbA1c at Week 30	Metformin, SGLT2is, SUs
SUSTAIN 10 35	Randomized, open‐label	Semaglutide s.c., liraglutide	30 weeks	Change from baseline in HbA1c at Week 30	1–3 OADs

Abbreviations: BID, twice‐daily; DPP4i, dipeptidyl peptidase‐4 inhibitor; exenatide ER, exenatide extended‐release; exenatide ER AI, exenatide ER auto‐injectable; GLP‐1 RA, glucagon‐like peptide‐1 receptor agonist; HbA_1c, glycated haemoglobin; MACE, major cardiovascular adverse events; OAD, oral anti‐diabetic; QD, once‐daily; QW, once‐weekly; s.c., subcutaneous; SGLT2i, sodium‐glucose cotransporter‐2 inhibitor; SU, sulphonylurea; TZD, thiazolidinedione.