Table 2

Safety assessments, change from baseline in vital signs, and TE dulaglutide ADAs

26 weeks52 weeks
VariableDulaglutide
1.5 mg
(n = 279)Dulaglutide
0.75 mg
(n = 280)Exenatide
(n = 276)Placebo
(n = 141)Dulaglutide
1.5 mg
(n = 279)Dulaglutide
0.75 mg
(n = 280)Exenatide
(n = 276)
Death1 (0.4)1 (0.4)0 (0)0 (0)1 (0.4)1 (0.4)0 (0)
Serious AEs, n (%)12 (4)15 (5)15 (5)12 (9)18 (7)22 (8)27 (10)
AEs (patients with ≥1 event)215 (77)199 (71)198 (72)104 (74)226 (81)220 (79)221 (80)
TE AEs (≥5% patients)
 GI events131 (47)**83 (30)#*117 (42)**26 (18)142 (51)94 (34)#128 (46
  Nausea78 (28)**45 (16)#*71 (26)**8 (6)81 (29)47 (17)#77 (28)
  Vomiting47 (17)#**17 (6)#*30 (11)**2 (1)47 (17)17 (6)#33 (12)
  Diarrhea31 (11)22 (8)16 (6)8 (6)36 (13)26 (9)21 (8)
  Dyspepsia22 (8)*5 (2)#19 (7)4 (3)23 (8)6 (2)#20 (7)
  Constipation12 (4)5 (2)5 (2)2 (1)16 (6)#5 (2)5 (2)
  Flatulence14 (5)3 (1)6 (2)3 (2)16 (6)3 (1)7 (3)
 Infections and infestations74 (27)74 (26)78 (28)43 (31)110 (39)101 (36)107 (39)
  Nasopharyngitis18 (7)23 (8)12 (4)8 (6)27 (10)26 (9)16 (6)
  URI12 (4)14 (5)12 (4)6 (4)15 (5)23 (8)19 (7)
  UTI12 (4)8 (3)7 (3)4 (3)17 (6)13 (5)13 (5)
 Headache20 (7)9 (3)24 (9)8 (6)26 (9)14 (5)24 (9)
 Fatigue10 (4)#12 (4)21 (8)*2 (1)13 (5)13 (5)22 (8)
 Decreased appetite22 (8)#*14 (5)8 (3)3 (2)23 (8)#15 (5)9 (3)
 Peripheral edema3 (1)13 (5)11 (4)7 (5)8 (3)15 (5)17 (6)
 Back pain11 (4)9 (3)8 (3)9 (6)15 (5)13 (5)12 (4)
 Dizziness15 (5)8 (3)#18 (7)*2 (1)18 (7)9 (3)21 (8)
 Arthralgia8 (3)10 (4)9 (3)3 (2)10 (4)16 (6)13 (5)
 Pain in extremity6 (2)8 (3)8 (3)6 (4)11 (4)13 (5)13 (5)
Discontinuation due to AE8 (3)4 (1)9 (3)3 (2)9 (3)4 (1)10 (4)
Safety parameters
 SBP (mmHg)0.11 ± 0.83*−0.36 ± 0.82*0.06 ± 0.83*3.40 ± 1.130.83 ± 0.871.62 ± 0.850.02 ± 0.88
 DBP (mmHg)0.76 ± 0.550.56 ± 0.54−0.11 ± 0.551.25 ± 0.750.89 ± 0.570.76 ± 0.570.02 ± 0.58
 Heart rate (beats/min)2.80 ± 0.52#*2.80 ± 0.51#*1.18 ± 0.520.61 ± 0.701.68 ± 0.561.56 ± 0.551.15 ± 0.56
ADAsa
 Dulaglutide ADAs4 (1.4)2 (0.7)12 (4.3)2 (1.4)5 (1.8)3 (1.1)14 (5.1)
 Exenatide ADAs75 (27.2)58 (21.0)
  • Data are n (%) and LS mean ± SE. AE, adverse event; DBP, diastolic blood pressure; GI, gastrointestinal; SBP, systolic blood pressure; TE, treatment emergent; URI, upper respiratory infection; UTI, urinary tract infection.

  • aDulaglutide ADA values are treatment emergent; exenatide ADA values are total reported ADAs.

  • **P < 0.001 vs. placebo.

  • #P < 0.05 vs. exenatide.

  • *P < 0.05 vs. placebo.