Table 4.

Summary of dulaglutide studies: the pivotal studies were termed the AWARD series. The dosages of dulaglutide studied were 0.75 mg and 1.5 mg.

Study	Intervention medication	Population, duration	Mean % change in HbA1c	Mean change in body weight	GI adverse events
Wysham et al. [2014] AWARD-1	Dulaglutide 1.5 mg weekly Dulaglutide 0.75 mg weekly Exenatide 10 µg twice daily Placebo	Metformin, pioglitazone treated (n = 976) 52 weeks	Dulaglutide 1.5 mg: –1.51% (p < 0.001 versus placebo and exenatide) Dulaglutide 0.75 mg: –1.30% (p < 0.001 versus placebo and exenatide) Exenatide: –0.99% Placebo: –0.46%	Dulaglutide 1.5 mg: −1.30 kg (p < 0.001 versus placebo) Dulaglutide 0.75 mg: 0.20 kg (p = 0.01 versus placebo) Exenatide: −1.07 kg (p < 0.001 versus placebo) Placebo: +1.24 kg	Dulaglutide 1.5 mg: nausea (28% at 26 weeks and 29% at 52 weeks), vomiting (17% at 26 weeks and 17% at 52 weeks) Dulaglutide 0.75 mg: nausea (16% at 26 weeks and 17% at 52 weeks), vomiting (6% at 26 weeks and 6% at 52 weeks) Exenatide: nausea (26% at 26 weeks), vomiting (11% at 26 weeks). Placebo: nausea (6% at 26 weeks), vomiting (1% at 26 weeks)
Umpierrez et al. [2014] AWARD-3	Dulaglutide 1.5 mg weekly Dulaglutide 0.75 mg weekly Metformin	Diet and exercise or low-dose oral hypoglycemic treated (n = 807) 52 weeks	Dulaglutide 1.5 mg: –0.78% Dulaglutide 0.75 mg: –0.71% (p < 0.025 for both doses versus metformin) Metformin: –0.56%	Dulaglutide 1.5 mg: −2.29 kg (p < 0.003 for both doses versus metformin) Dulaglutide 0.75 mg: −1.36 kg Metformin: −2.22 kg	Dulaglutide 1.5 mg: nausea (19% at 26 weeks and 19.7% at 52 weeks), vomiting (8% at 26 weeks and 9.6% at 52 weeks) Dulaglutide 0.75 mg: nausea (10.7% at 26 weeks and 11.5% at 52 weeks), vomiting (8% at 26 weeks and 9.6% at 52 weeks) Metformin: nausea (14.6% at 26 weeks and 19.7% at 52 weeks), vomiting (4.1% at 26 weeks and 4.9% at 52 weeks)
Nauck et al. [2014] AWARD-5	Dulaglutide 0.75 mg weekly Dulaglutide 1.5 mg weekly Sitagliptin 100 mg daily	Metformin treated (n = 1098) 52 weeks	Dulaglutide 1.5 mg: –1.10% Dulaglutide 0.75 mg: –0.87% (p < 0.001 for both doses versus sitagliptin) Sitagliptin 100 mg: –0.39%	Dulaglutide 1.5 mg: –3.03 kg (p < 0.001 versus sitagliptin) Dulaglutide 0.75 mg: –2.60 kg (p < 0.001 versus sitagliptin) Sitagliptin: –1.53 kg	Dulaglutide 1.5 mg: nausea (17% at 52 weeks), vomiting (13% at 52 weeks) Dulaglutide 0.75 mg: nausea (14% at 52 weeks), vomiting (8% at 52 weeks) Sitagliptin: nausea (5% at 52 weeks), vomiting (2% at 52 weeks)
Dungan et al. [2014] AWARD-6	Dulaglutide 1.5 mg weekly Liraglutide 1.8 mg	Metformin treated (n = 599) 26 weeks	Dulaglutide 1.5 mg: –1·42% Liraglutide 1.8 mg: –1·36% Mean difference: –0.06% (95% CI –0.19 to 0.07, p noninferiority < 0.0001) between the two groups	Dulaglutide: −2·90 kg (p < 0.0001) Liraglutide: −3.61 kg (p < 0.0001) Mean difference: 0.71 (95% CI 0.17–1.26)	Dulaglutide: nausea (20%), diarrhea (12%), vomiting (7%) Liraglutide: nausea (18%), diarrhea (12%), vomiting (8%)
Giorgino et al. [2014] AWARD -2	Dulaglutide 1.5 mg, Dulaglutide 0.75 mg Basal insulin as add on to metformin and glimepiride	Metformin and glimepiride treated (n = 807) 52 weeks	Dulaglutide 1.5 mg: –1.08% Dulaglutide 0.75 mg: –0.76% Basal insulin: –0.63% (p < 0.001 versus insulin glargine)	Not reported	Not reported

AWARD, Assessment of Weekly AdministRation of Dulaglutide; CI, confidence interval; HbA1c, hemoglobin A1c; GI, gastrointestinal.