Table 2.
Safety assessments up to week 52.
| Dulaglutide 0.75 mg (N = 280) | Liraglutide 0.9 mg (N = 137) | p | |
|---|---|---|---|
| Deaths | 0 | 0 | NA |
| Serious adverse events* | 9 (3.2) | 7 (5.1) | 0.416 |
| Patients with at least one treatment‐emergent adverse event | 185 (66.1) | 94 (68.6) | 0.658 |
| Treatment‐emergent adverse events (≥5% in either group) | |||
| Nasopharyngitis | 52 (18.6) | 24 (17.5) | 0.893 |
| Decreased appetite | 2 (0.7) | 8 (5.8) | 0.003 |
| Gastrointestinal disorders | 76 (27.1) | 51 (37.2) | 0.041 |
| Constipation | 22 (7.9) | 11 (8.0) | >0.999 |
| Diarrhoea | 20 (7.1) | 6 (4.4) | 0.388 |
| Nausea | 17 (6.1) | 11 (8.0) | 0.532 |
| Abdominal distension | 12 (4.3) | 7 (5.1) | 0.803 |
| Patients who discontinued study because of an adverse event | 5 (1.8) | 4 (2.9) | 0.484 |
| Seated vital signs, mean change from baseline (s.e.)†, ‡ | |||
| Systolic blood pressure, mmHg | 1.45 (0.64) | −1.58 (0.92) | 0.007 |
| Diastolic blood pressure, mmHg | 1.56 (0.40) | 1.27 (0.58) | 0.680 |
| Pulse rate, bpm | 3.45 (0.42) | 4.99 (0.60) | 0.036 |
| ECG PR interval: mean change from baseline (s.e.), ms;† | 2.81 (0.82) | 3.71 (1.03) | 0.398 |
| Pancreatic enzymes (median change, Q1, Q3) | |||
| Total amylase, U/l‡ | 7.0 (1.0, 14.0)** | 6.0 (1.0, 11.0)** | 0.206 |
| Lipase, U/l‡ | 6.0 (1.0, 12.0)** | 9.0 (3.0, 19.0)** | <0.001 |
| Patients with treatment‐emergent abnormal change in pancreatic enzymes (>ULN)§ | |||
| Total amylase | 19/261 (7.3) | 9/124 (7.3) | 1.000 |
| Lipase | 67/254 (26.4) | 44/121 (36.4) | 0.053 |
| Patients with pancreatic enzyme concentration >3 × ULN | |||
| Total amylase | 1 (0.4) | 0 | 1.000 |
| Lipase | 5 (1.8) | 2 (1.5) | 1.000 |
| Treatment‐emergent dulaglutide antidrug antibodies¶ | |||
| Dulaglutide antidrug antibodies | 3 (1.1) | 0 | NA |
| Dulaglutide neutralizing antidrug antibodies | 2 (0.7) | 0 | NA |
| nsGLP‐1 cross‐reactive antibodies | 2 (0.7) | 0 | NA |
| nsGLP‐1 neutralizing antibodies | 0 | 0 | NA |
| Both nsGLP‐1 neutralizing and cross‐reactive antibodies | 0 | 0 | NA |
**
p < 0.001 within‐group.
Data are n (%) unless otherwise specified. MedDRA, Medical Dictionary for Regulatory Activities (version 17.0); N, number of patients in safety analysis set; NA, not applicable; nsGLP‐1, native sequence glucagon‐like peptide‐1; Q1, first quartile; Q3, third quartile; s.e., standard error; ULN, upper limit of normal.
*
Reported serious adverse events are listed in Table S2.
†
Data are least‐squares mean change (s.e.).
‡
Data are last observation carried forward.
§
Denominator is patients with enzyme level ≤ ULN at baseline and a postbaseline measurement.
¶
These values include all postbaseline observations including the safety follow‐up.