Table 2.
Safety assessments, change from baseline in vital signs, and TE dulaglutide ADAs through 26 and 52 weeks
| Variable | 26 weeks |
52 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) | |
| Death | 1 (<1) | 0 (0) | 0 (0) | 0 (0) | 1 (<1) | 0 (0) | 2 (<1) |
| Serious adverse events | 17 (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 events | 116 (38)##,** | 97 (32)##,* | 55 (18) | 41 (23) | 126 (41)## | 111 (37)## | 73 (23) |
| Nausea | 51 (17)##,** | 38 (13)##,* | 14 (4) | 7 (4) | 53 (17)## | 42 (14)## | 16 (5) |
| Vomiting | 36 (12)##,** | 22 (7)#,** | 6 (2) | 1 (1) | 39 (13)## | 23 (8)# | 7 (2) |
| Diarrhea | 39 (13)##,* | 27 (9)## | 8 (3)* | 11 (6) | 44 (15)## | 30 (10)## | 9 (3) |
| Abdominal pain | 13 (4) | 11 (4) | 6 (2) | 3 (2) | 18 (6) | 12 (4) | 10 (3) |
| Dyspepsia | 13 (4) | 14 (5) | 8 (3) | 2 (1) | 14 (5) | 18 (6) | 9 (3) |
| Abdominal distension | 12 (4) | 12 (4) | 3 (1) | 1 (1) | 12 (4) | 14 (5) | 3 (1) |
| SOC: infections and infestations | 89 (29) | 71 (24) | 74 (24) | 36 (20) | 111 (37) | 97 (32) | 101 (32) |
| Nasopharyngitis | 25 (8) | 24 (8) | 26 (8) | 13 (7) | 35 (12) | 35 (12) | 36 (11) |
| URI | 12 (4) | 12 (4) | 4 (1) | 2 (1) | 16 (5) | 16 (5) | 12 (4) |
| UTI | 11 (4) | 16 (5) | 11 (4) | 9 (5) | 15 (5) | 18 (6) | 15 (5) |
| Other adverse eventsa | |||||||
| Hyperglycemia | 4 (1)#,** | 5 (2)#,** | 14 (4)* | 19 (11) | 16 (5) | 23 (8) | 29 (9) |
| Decreased appetite | 29 (10)##,** | 16 (5)# | 5 (2) | 3 (2) | 29 (10)## | 17 (6)# | 7 (2) |
| Back pain | 12 (4) | 13 (4) | 10 (3) | 7 (4) | 15 (5) | 18 (6) | 15 (5) |
| Headache | 20 (7) | 20 (7) | 19 (6) | 9 (5) | 26 (9) | 23 (8) | 23 (7) |
| Arthralgia | 7 (2) | 10 (3) | 4 (1) | 4 (2) | 11 (4) | 14 (5) | 8 (3) |
| Dizziness | 3 (1) | 13 (4) | 8 (3) | 4 (2) | 5 (2) | 14 (5) | 10 (3) |
| Discontinuation due to adverse events | 21 (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 ± 0.6 | 0.3 ± 0.5 | 0.2 ± 0.5 | −0.2 ± 0.5 |
| Pulse rate (bpm) | 2.6 ± 0.5##,** | 1.9 ± 0.5#,* | −0.1 ± 0.5 | −0.2 ± 0.7 | 2.4 ± 0.5## | 2.1 ± 0.5## | −0.3 ± 0.5 |
| TE dulaglutide ADAs | |||||||
| Dulaglutide ADAs | 2 (<1) | 6 (2) | 1 (<1) | 0 (0) | 2 (<1) | 7 (2) | 2 (<1) |
| Neutralizing dulaglutide ADAs | 2 (<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.