Cardiovascular safety for once-weekly dulaglutide in type 2 diabetes: a pre-specified meta-analysis of prospectively adjudicated cardiovascular events

Table 1 Phase 2 and Phase 3 dulaglutide studies included in cardiovascular meta-analysis

Study	Reference	Patients randomized		Dulaglutide doses (mg)	Treatment duration (weeks)	Comparators	Background therapy
Study	Reference	All (N)	Dulaglutide (n)	Dulaglutide doses (mg)	Treatment duration (weeks)	Comparators	Background therapy
Phase 2 studies
Dose titration^a	[14]	262	196	0.5 → 1.0, 1.0, 1.0 → 2.0	16	Placebo	2 OAMs
Monotherapy^a	[15]	167	135	0.1, 0.5, 1.0, 1.5	12	Placebo	None
Japanese study^a	[16]	145	108	0.25, 0.5, 0.75	12	Placebo	None
ABPM study^a	[17]	755	505	0.75, 1.5	26	Placebo	≥1 OAM
Phase 3 studies
AWARD-1^b	[18]	978	559	0.75, 1.5	52	Placebo, exenatide	Metformin + pioglitazone
AWARD-2^b	[19]	810	545	0.75, 1.5	78	Glargine	Metformin + glimepiride
AWARD-3^a	[20]	807	539	0.75, 1.5	52	Metformin	None
AWARD-4^b	[21]	884	588	0.75, 1.5	52	Glargine	Lispro ± metformin
AWARD-5^a	[22, 23]	1202	710	Stage 2: 0.75, 1.5	104	Placebo, sitagliptin	Metformin

ABPM ambulatory blood pressure monitoring, AWARD Assessment of Weekly AdministrRation of LY2189265 (dulaglutide) in Diabetes, OAM oral anti-diabetic medication
^aDouble-blind studies
^bOpen-label studies

ISSN: 1475-2840