Table 2

Safety assessments

52 weeks*78 weeks*
DulaglutideGlargineDulaglutideGlargine
1.5 mg0.75 mg1.5 mg0.75 mg
VariableN = 273N = 272N = 262N = 273N = 272N = 262
Death, n (%)0 (0)0 (0)2 (0.8)0 (0.0)1 (0.4)2 (0.8)
Serious adverse events, n (%)24 (8.8)23 (8.5)28 (10.7)32 (11.7)28 (10.3)32 (12.2)
TEAEs (patients with ≥1 event), n (%)189 (69.2)175 (64.3)175 (66.8)201 (73.6)188 (69.1)192 (73.3)
TEAEs (≥5% patients), n (%)
 Gastrointestinal events
  Diarrhea29 (10.6)#23 (8.5)#10 (3.8)29 (10.6)25 (9.2)15 (5.7)
  Nausea39 (14.3)##18 (6.6)#4 (1.5)42 (15.4)##21 (7.7)##4 (1.5)
  Dyspepsia18 (6.6)#9 (3.3)6 (2.3)19 (7.0)#9 (3.3)6 (2.3)
  Vomiting17 (6.2)#9 (3.3)3 (1.1)18 (6.6)#10 (3.7)3 (1.1)
  Abdominal pain upper13 (4.8)#8 (2.9)2 (0.8)14 (5.1)#9 (3.3)#2 (0.8)
 Infections and infestations
  Bronchitis5 (1.8)4 (1.5)9 (3.4)9 (3.3)6 (2.2)14 (5.3)
  Influenza11 (4.0)13 (4.8)10 (3.8)12 (4.4)13 (4.8)13 (5.0)
  Nasopharyngitis13 (4.8)7 (2.6)17 (6.5)15 (5.5)12 (4.4)23 (8.8)
  Upper respiratory tract infection14 (5.1)7 (2.6)14 (5.3)15 (5.5)10 (3.7)17 (6.5)
  Urinary tract infection8 (2.9)12 (4.4)11 (4.2)11 (4.0)16 (5.9)15 (5.7)
 Nervous system disorders
  Headache21 (7.7)7 (2.6)10 (3.8)22 (8.1)9 (3.3)13 (5.0)
 Discontinuation due to an AE, n (%)8 (2.9)7 (2.6)4 (1.5)9 (3.3)8 (2.9)5 (1.9)
Pancreatic enzymes, mean ± SD (units/L)
 Lipase (baseline)56.6 ± 64.747.6 ± 47.146.5 ± 32.956.6 ± 64.747.6 ± 47.146.5 ± 32.9
 Lipase Δ4.7 ± 63.84.3 ± 54.42.2 ± 81.43.9 ± 66.29.3 ± 61.6−4.0 ± 33.1
 Total amylase (baseline)68.6 ± 36.463.0 ± 29.562.1 ± 29.368.6 ± 36.463.0 ± 29.562.1 ± 29.3
 Total amylase Δ5.4 ± 31.24.5 ± 21.41.6 ± 28.86.4 ± 32.35.2 ± 21.80.76 ± 25.8
 Pancreatic amylase (baseline)34.0 ± 27.429.4 ± 20.629.1 ± 19.534.0 ± 27.429.4 ± 20.629.1 ± 19.5
 Pancreatic amylase Δ3.6 ± 25.62.9 ± 18.81.4 ± 26.23.9 ± 30.33.8 ± 18.1−0.38 ± 19.4
Patients with at least 1 TE abnormality, n (%)
 Lipase97 (35.5)##76 (27.9)#46 (17.6)102 (37.4)##85 (31.3)#50 (19.1)
 Total amylase43 (15.8)#37 (13.6)22 (8.4)43 (15.8)#42 (15.4)#24 (9.2)
 Pancreatic amylase42 (15.4)51 (18.8)#29 (11.1)44 (16.1)61 (22.4)#34 (13.0)
Pancreatic enzymes, n (%) patients with >3× ULN§
 Lipase (baseline)11 (4.0)4 (1.5)8 (3.1)11 (4.0)4 (1.5)8 (3.1)
 Lipase38 (14.1)##20 (7.5)14 (5.4)45 (16.7)##23 (8.6)14 (5.4)
 Total amylase (baseline)000000
 Total amylase4 (1.5)1 (0.4)1 (0.4)4 (1.5)1 (0.4)1 (0.4)
 Pancreatic amylase (baseline)4 (1.5)2 (0.7)1 (0.4)4 (1.5)2 (0.7)1 (0.4)
 Pancreatic amylase12 (4.5)7 (2.6)3 (1.2)14 (5.2)10 (3.7)4 (1.6)
Vital signs
 Blood pressure (mmHg) 
  Systolic (baseline)132 ± 16131 ± 14130 ± 16132 ± 16131 ± 14130 ± 16
  Systolic Δ0.17 ± 0.810.09 ± 0.800.51 ± 0.83−0.70 ± 0.85−0.59 ± 0.850.51 ± 0.87
  Diastolic (baseline)79 ± 979 ± 978 ± 979 ± 979 ± 978 ± 9
  Diastolic Δ−0.26 ± 0.48−0.19 ± 0.47−0.93 ± 0.49−0.44 ± 0.52−0.36 ± 0.52−1.04 ± 0.53
 Heart rate (bpm) (baseline)76.14 ± 9.7476.99 ± 10.0576.72 ± 9.2476.14 ± 9.7476.99 ± 10.0576.72 ± 9.24
 Heart rate Δ1.29 ± 0.50#0.51 ± 0.49−0.52 ± 0.511.31 ± 0.50#0.61 ± 0.50#−0.91 ± 0.51
  • Δ, change from baseline at 52 or 78 weeks; TEAE, treatment-emergent adverse event.

  • *For all adverse events, an overall P value was calculated. Pairwise P values were reported only to compare with glargine and only when the overall P ≤ 0.05 and both groups had events.

  • †The 78-week count data are cumulative and include data through 52 weeks.

  • ‡Patients with at least 1 treatment-emergent abnormality during the time period assessed.

  • §Patients with at least 1 value >3× ULN during the time period assessed.

  • ‖Baseline data are presented as mean ± SD; change from baseline data are presented as LS mean ± SE.

  • #P < 0.05 vs. glargine.

  • ##P < 0.001 vs. glargine.