Safety assessments
| 52 weeks* | 78 weeks*† | |||||
|---|---|---|---|---|---|---|
| Dulaglutide | Glargine | Dulaglutide | Glargine | |||
| 1.5 mg | 0.75 mg | 1.5 mg | 0.75 mg | |||
| Variable | N = 273 | N = 272 | N = 262 | N = 273 | N = 272 | N = 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 | ||||||
| Diarrhea | 29 (10.6)# | 23 (8.5)# | 10 (3.8) | 29 (10.6) | 25 (9.2) | 15 (5.7) |
| Nausea | 39 (14.3)## | 18 (6.6)# | 4 (1.5) | 42 (15.4)## | 21 (7.7)## | 4 (1.5) |
| Dyspepsia | 18 (6.6)# | 9 (3.3) | 6 (2.3) | 19 (7.0)# | 9 (3.3) | 6 (2.3) |
| Vomiting | 17 (6.2)# | 9 (3.3) | 3 (1.1) | 18 (6.6)# | 10 (3.7) | 3 (1.1) |
| Abdominal pain upper | 13 (4.8)# | 8 (2.9) | 2 (0.8) | 14 (5.1)# | 9 (3.3)# | 2 (0.8) |
| Infections and infestations | ||||||
| Bronchitis | 5 (1.8) | 4 (1.5) | 9 (3.4) | 9 (3.3) | 6 (2.2) | 14 (5.3) |
| Influenza | 11 (4.0) | 13 (4.8) | 10 (3.8) | 12 (4.4) | 13 (4.8) | 13 (5.0) |
| Nasopharyngitis | 13 (4.8) | 7 (2.6) | 17 (6.5) | 15 (5.5) | 12 (4.4) | 23 (8.8) |
| Upper respiratory tract infection | 14 (5.1) | 7 (2.6) | 14 (5.3) | 15 (5.5) | 10 (3.7) | 17 (6.5) |
| Urinary tract infection | 8 (2.9) | 12 (4.4) | 11 (4.2) | 11 (4.0) | 16 (5.9) | 15 (5.7) |
| Nervous system disorders | ||||||
| Headache | 21 (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 ± 64.7 | 47.6 ± 47.1 | 46.5 ± 32.9 | 56.6 ± 64.7 | 47.6 ± 47.1 | 46.5 ± 32.9 |
| Lipase Δ | 4.7 ± 63.8 | 4.3 ± 54.4 | 2.2 ± 81.4 | 3.9 ± 66.2 | 9.3 ± 61.6 | −4.0 ± 33.1 |
| Total amylase (baseline) | 68.6 ± 36.4 | 63.0 ± 29.5 | 62.1 ± 29.3 | 68.6 ± 36.4 | 63.0 ± 29.5 | 62.1 ± 29.3 |
| Total amylase Δ | 5.4 ± 31.2 | 4.5 ± 21.4 | 1.6 ± 28.8 | 6.4 ± 32.3 | 5.2 ± 21.8 | 0.76 ± 25.8 |
| Pancreatic amylase (baseline) | 34.0 ± 27.4 | 29.4 ± 20.6 | 29.1 ± 19.5 | 34.0 ± 27.4 | 29.4 ± 20.6 | 29.1 ± 19.5 |
| Pancreatic amylase Δ | 3.6 ± 25.6 | 2.9 ± 18.8 | 1.4 ± 26.2 | 3.9 ± 30.3 | 3.8 ± 18.1 | −0.38 ± 19.4 |
| Patients with at least 1 TE abnormality, n (%)‡ | ||||||
| Lipase | 97 (35.5)## | 76 (27.9)# | 46 (17.6) | 102 (37.4)## | 85 (31.3)# | 50 (19.1) |
| Total amylase | 43 (15.8)# | 37 (13.6) | 22 (8.4) | 43 (15.8)# | 42 (15.4)# | 24 (9.2) |
| Pancreatic amylase | 42 (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) |
| Lipase | 38 (14.1)## | 20 (7.5) | 14 (5.4) | 45 (16.7)## | 23 (8.6) | 14 (5.4) |
| Total amylase (baseline) | 0 | 0 | 0 | 0 | 0 | 0 |
| Total amylase | 4 (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 amylase | 12 (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 ± 16 | 131 ± 14 | 130 ± 16 | 132 ± 16 | 131 ± 14 | 130 ± 16 |
| Systolic Δ | 0.17 ± 0.81 | 0.09 ± 0.80 | 0.51 ± 0.83 | −0.70 ± 0.85 | −0.59 ± 0.85 | 0.51 ± 0.87 |
| Diastolic (baseline) | 79 ± 9 | 79 ± 9 | 78 ± 9 | 79 ± 9 | 79 ± 9 | 78 ± 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 ± 9.74 | 76.99 ± 10.05 | 76.72 ± 9.24 | 76.14 ± 9.74 | 76.99 ± 10.05 | 76.72 ± 9.24 |
| Heart rate Δ | 1.29 ± 0.50# | 0.51 ± 0.49 | −0.52 ± 0.51 | 1.31 ± 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.