Table 2

Safety assessments, change from baseline in vital signs, and TE dulaglutide ADAs through 26 and 52 weeks

Variable26 weeks52 weeks
DU 1.5 mg (N = 304)DU 0.75 mg (N = 302)SITA (N = 315)PL (N = 177)DU 1.5 mg (N = 304)DU 0.75 mg (N = 302)SITA (N = 315)
Death1 (<1)0 (0)0 (0)0 (0)1 (<1)0 (0)2 (<1)
Serious adverse events17 (6)10 (3)11 (4)6 (3)26 (9)16 (5)17 (5)
Adverse events, (patients with ≥1 event)208 (68)#204 (68)#185 (59)111 (63)233 (77)231 (77)219 (70)
TE adverse events, (≥5% patients)
 SOC: GI events116 (38)##,**97 (32)##,*55 (18)41 (23)126 (41)##111 (37)##73 (23)
  Nausea51 (17)##,**38 (13)##,*14 (4)7 (4)53 (17)##42 (14)##16 (5)
  Vomiting36 (12)##,**22 (7)#,**6 (2)1 (1)39 (13)##23 (8)#7 (2)
  Diarrhea39 (13)##,*27 (9)##8 (3)*11 (6)44 (15)##30 (10)##9 (3)
  Abdominal pain13 (4)11 (4)6 (2)3 (2)18 (6)12 (4)10 (3)
  Dyspepsia13 (4)14 (5)8 (3)2 (1)14 (5)18 (6)9 (3)
  Abdominal distension12 (4)12 (4)3 (1)1 (1)12 (4)14 (5)3 (1)
 SOC: infections and infestations89 (29)71 (24)74 (24)36 (20)111 (37)97 (32)101 (32)
  Nasopharyngitis25 (8)24 (8)26 (8)13 (7)35 (12)35 (12)36 (11)
  URI12 (4)12 (4)4 (1)2 (1)16 (5)16 (5)12 (4)
  UTI11 (4)16 (5)11 (4)9 (5)15 (5)18 (6)15 (5)
 Other adverse eventsa
  Hyperglycemia4 (1)#,**5 (2)#,**14 (4)*19 (11)16 (5)23 (8)29 (9)
  Decreased appetite29 (10)##,**16 (5)#5 (2)3 (2)29 (10)##17 (6)#7 (2)
  Back pain12 (4)13 (4)10 (3)7 (4)15 (5)18 (6)15 (5)
  Headache20 (7)20 (7)19 (6)9 (5)26 (9)23 (8)23 (7)
  Arthralgia7 (2)10 (3)4 (1)4 (2)11 (4)14 (5)8 (3)
  Dizziness3 (1)13 (4)8 (3)4 (2)5 (2)14 (5)10 (3)
Discontinuation due to adverse events21 (7)12 (4)14 (4)24 (14)33 (11)23 (8)30 (10)
Vital signs
 SBP (mmHg)−1.7 ± 0.7*−1.4 ± 0.7*−1.9 ± 0.7*1.1 ± 0.9−0.8 ± 0.7−0.5 ± 0.7−0.5 ± 0.7
 DBP (mmHg)−0.4 ± 0.4−0.2 ± 0.4−1.1 ± 0.4*0.7 ± 0.60.3 ± 0.50.2 ± 0.5−0.2 ± 0.5
 Pulse rate (bpm)2.6 ± 0.5##,**1.9 ± 0.5#,*−0.1 ± 0.5−0.2 ± 0.72.4 ± 0.5##2.1 ± 0.5##−0.3 ± 0.5
TE dulaglutide ADAs
 Dulaglutide ADAs2 (<1)6 (2)1 (<1)0 (0)2 (<1)7 (2)2 (<1)
 Neutralizing dulaglutide ADAs2 (<1)0 (0)0 (0)0 (0)2 (<1)0 (0)0 (0)
  • Data are n (%) or LS mean (± SE) unless otherwise indicated.

  • DU, dulaglutide; PL, placebo; SITA, sitagliptin; SOC, system organ class; URI, upper respiratory infection; UTI, urinary tract infection.

  • #, *P < 0.05 vs. sitagliptin and placebo, respectively.

  • ##, **P < 0.001 vs. sitagliptin and placebo, respectively.

  • aMultiple SOCs.