Table 1.
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