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. 2016 Feb 24;15:38. doi: 10.1186/s12933-016-0355-z

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
All (N) Dulaglutide (n)
Phase 2 studies
Dose titrationa [14] 262 196 0.5 → 1.0, 1.0, 1.0 → 2.0 16 Placebo 2 OAMs
Monotherapya [15] 167 135 0.1, 0.5, 1.0, 1.5 12 Placebo None
Japanese studya [16] 145 108 0.25, 0.5, 0.75 12 Placebo None
ABPM studya [17] 755 505 0.75, 1.5 26 Placebo ≥1 OAM
Phase 3 studies
AWARD-1b [18] 978 559 0.75, 1.5 52 Placebo, exenatide Metformin + pioglitazone
AWARD-2b [19] 810 545 0.75, 1.5 78 Glargine Metformin + glimepiride
AWARD-3a [20] 807 539 0.75, 1.5 52 Metformin None
AWARD-4b [21] 884 588 0.75, 1.5 52 Glargine Lispro ± metformin
AWARD-5a [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