Table 2.
Proportion of participants experiencing adverse events according to baseline age and body mass index subgroups in the SUSTAIN Japan monotherapy trial and the SUSTAIN Japan OAD Combination trial
| SUSTAIN Japan monotherapy trial | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| OW semaglutide 0.5 mg | OW semaglutide 1.0 mg | Sitagliptin | ||||||||||
| Age (years) | <65 | ≥65 | <65 | ≥65 | <65 | ≥65 | ||||||
| BMI (kg/m2) | <25 | ≥25 | <25 | ≥25 | <25 | ≥25 | <25 | ≥25 | <25 | ≥25 | <25 | ≥25 |
| N | 32 | 34 | 25 | 12 | 29 | 34 | 27 | 12 | 37 | 36 | 22 | 8 |
| Any AE, n (%) | 23 (71.9) | 25 (73.5) | 19 (76.0) | 10 (83.3) | 23 (79.3) | 21 (61.8) | 19 (70.4) | 10 (83.3) | 25 (67.6) | 22 (61.1) | 16 (72.7) | 5 (62.5) |
| E | 67 | 53 | 68 | 40 | 59 | 70 | 36 | 32 | 64 | 64 | 43 | 15 |
| R | 311.1 | 230.9 | 411.4 | 519.6 | 332.9 | 315.7 | 231.1 | 424.4 | 258.4 | 261.9 | 287.8 | 277.3 |
| Severity of AE, n (%) | ||||||||||||
| Mild AE | 21 (65.6) | 24 (70.6) | 18 (72.0) | 10 (83.3) | 22 (75.9) | 18 (52.9) | 19 (70.4) | 9 (75.0) | 25 (67.6) | 22 (61.1) | 15 (68.2) | 5 (62.5) |
| Moderate AE | 3 (9.4) | 4 (11.8) | 4 (16.0) | 2 (16.7) | 3 (10.3) | 5 (14.7) | 0 | 1 (8.3) | 6 (16.2) | 2 (5.6) | 2 (9.1) | 0 |
| Severe AE | 0 | 0 | 0 | 2 (16.7) | 0 | 1 (2.9) | 0 | 0 | 1 (2.7) | 0 | 1 (4.5) | 0 |
| Serious AEs, n (%) | 2 (6.3) | 0 | 1 (4.0) | 3 (25.0) | 1 (3.4) | 1 (2.9) | 0 | 0 | 1 (2.7) | 0 | 1 (4.5) | 0 |
| E | 2 | 0 | 2 | 3 | 1 | 1 | 0 | 0 | 2 | 0 | 1 | 0 |
| R | 9.3 | 0 | 12.1 | 39.0 | 5.6 | 4.5 | 0 | 0 | 8.1 | 0 | 6.7 | 0 |
| AE leading to premature treatment discontinuation, n (%) | 1 (3.1) | 0 | 1 (4.0) | 1 (8.3) | 4 (13.8) | 0 | 6 (22.2) | 1 (8.3) | 1 (2.7) | 0 | 1 (4.5) | 0 |
| E | 1 | 0 | 3 | 1 | 7 | 0 | 7 | 1 | 3 | 0 | 1 | 0 |
| R | 4.6 | 0 | 18.2 | 13.0 | 39.5 | 0 | 44.9 | 13.3 | 12.1 | 0 | 6.7 | 0 |
| GI AEs, n (%) | 10 (31.3) | 10 (29.4) | 12 (48.0) | 7 (58.3) | 12 (41.4) | 14 (41.2) | 11 (40.7) | 5 (41.7) | 6 (16.2) | 4 (11.1) | 4 (18.2) | 3 (37.5) |
| E | 19 | 14 | 20 | 10 | 17 | 38 | 14 | 13 | 10 | 7 | 4 | 7 |
| R | 88.2 | 61.0 | 121.0 | 129.9 | 95.9 | 171.4 | 89.9 | 172.4 | 40.4 | 28.6 | 26.8 | 129.4 |
| Nausea, n (%) | 4 (12.5) | 1 (2.9) | 3 (12.0) | 3 (25.0) | 4 (13.8) | 5 (14.7) | 4 (14.8) | 0 | 0 | 0 | 0 | 0 |
| Vomiting, n (%) | 0 | 2 (5.9) | 2 (8.0) | 0 | 0 | 2 (5.9) | 0 | 0 | 1 (2.7) | 0 | 0 | 0 |
| Diarrhea, n (%) | 0 | 2 (5.9) | 3 (12.0) | 2 (16.7) | 5 (17.2) | 2 (5.9) | 1 (3.7) | 1 (8.3) | 0 | 1 (2.8) | 1 (4.5) | 0 |
| Constipation, n (%) | 6 (18.8) | 2 (5.9) | 6 (24.0) | 1 (8.3) | 1 (3.4) | 6 (17.6) | 3 (11.1) | 2 (16.7) | 2 (5.4) | 1 (2.8) | 0 | 1 (12.5) |
| Abdominal discomfort, n (%) | 0 | 3 (8.8) | 1 (4.0) | 0 | 2 (6.9) | 3 (8.8) | 1 (3.7) | 1 (8.3) | 0 | 0 | 0 | 0 |
| Severe or BG‐confirmed symptomatic hypoglycemia † , n (%) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.7) | 0 | 0 | 0 | 0 | 0 |
| SUSTAIN Japan OAD Combination trial | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| OW semaglutide 0.5 mg | OW semaglutide 1.0 mg | Additional OAD | ||||||||||
| Age (years) | <65 | ≥65 | <65 | ≥65 | <65 | ≥65 | ||||||
| BMI (kg/m2) | <25 | ≥25 | <25 | ≥25 | <25 | ≥25 | <25 | ≥25 | <25 | ≥25 | <25 | ≥25 |
| N | 57 | 105 | 48 | 29 | 59 | 109 | 43 | 30 | 29 | 48 | 20 | 23 |
| Any AE, n (%) | 52 (91.2) | 88 (83.8) | 39 (81.3) | 27 (93.1) | 51 (86.4) | 93 (85.3) | 41 (95.3) | 27 (90.0) | 18 (62.1) | 37 (77.1) | 11 (55.0) | 20 (87.0) |
| E | 220 | 360 | 193 | 136 | 203 | 456 | 183 | 112 | 50 | 126 | 35 | 58 |
| R | 333.7 | 300.8 | 371.0 | 408.5 | 331.4 | 373.9 | 467.2 | 325.7 | 146.4 | 235.3 | 154.6 | 226.5 |
| Severity of AE, n (%) | ||||||||||||
| Mild AE | 50 (87.7) | 86 (81.9) | 39 (81.3) | 27 (93.1) | 51 (86.4) | 92 (84.4) | 40 (93.0) | 26 (86.7) | 16 (55.2) | 36 (75.0) | 10 (50.0) | 18 (78.3) |
| Moderate AE | 4 (7.0) | 16 (15.2) | 6 (12.5) | 3 (10.3) | 3 (5.1) | 17 (15.6) | 5 (11.6) | 4 (13.3) | 3 (10.3) | 4 (8.3) | 2 (10.0) | 6 (26.1) |
| Severe AE | 2 (3.5) | 6 (5.7) | 1 (2.1) | 1 (3.4) | 1 (1.7) | 1 (0.9) | 1 (2.3) | 0 | 1 (3.4) | 1 (2.1) | 0 | 0 |
| Serious AEs, n (%) | 4 (7.0) | 9 (8.6) | 4 (8.3) | 2 (6.9) | 1 (1.7) | 5 (4.6) | 5 (11.6) | 1 (3.3) | 2 (6.9) | 2 (4.2) | 1 (5.0) | 3 (13.0) |
| E | 4 | 11 | 7 | 3 | 1 | 6 | 5 | 1 | 3 | 2 | 1 | 4 |
| R | 6.1 | 9.2 | 13.5 | 9.0 | 1.6 | 4.9 | 12.8 | 2.9 | 8.8 | 3.7 | 4.4 | 15.6 |
| AE leading to premature treatment discontinuation, n (%) | 1 (1.8) | 5 (4.8) | 6 (12.5) | 2 (6.9) | 8 (13.6) | 6 (5.5) | 12 (27.9) | 0 | N/A | N/A | N/A | N/A |
| E | 1 | 5 | 7 | 3 | 10 | 10 | 20 | 0 | N/A | N/A | N/A | N/A |
| R | 1.5 | 4.2 | 13.5 | 9.0 | 16.3 | 8.2 | 51.1 | 0 | N/A | N/A | N/A | N/A |
| GI AEs, n (%) | 30 (52.6) | 48 (45.7) | 32 (66.7) | 19 (65.5) | 29 (49.2) | 55 (50.5) | 33 (76.7) | 13 (43.3) | 2 (6.9) | 11 (22.9) | 2 (10.0) | 9 (39.1) |
| E | 66 | 81 | 70 | 45 | 65 | 124 | 73 | 38 | 2 | 21 | 2 | 15 |
| R | 100.1 | 67.7 | 134.6 | 135.2 | 106.1 | 101.7 | 186.4 | 110.5 | 5.9 | 39.2 | 8.8 | 58.6 |
| Nausea, n (%) | 6 (10.5) | 7 (6.7) | 10 (20.8) | 6 (20.7) | 8 (13.6) | 18 (16.5) | 16 (37.2) | 4 (13.3) | 0 | 0 | 0 | 1 (4.3) |
| Vomiting, n (%) | 3 (5.3) | 4 (3.8) | 4 (8.3) | 2 (6.9) | 4 (6.8) | 5 (4.6) | 3 (7.0) | 2 (6.7) | 0 | 0 | 0 | 2 (8.7) |
| Diarrhea, n (%) | 3 (5.3) | 10 (9.5) | 9 (18.8) | 2 (6.9) | 11 (18.6) | 17 (15.6) | 7 (16.3) | 3 (10.0) | 0 | 5 (10.4) | 0 | 3 (13.0) |
| Constipation, n (%) | 10 (17.5) | 16 (15.2) | 13 (27.1) | 6 (20.7) | 10 (16.9) | 12 (11.0) | 9 (20.9) | 5 (16.7) | 1 (3.4) | 3 (6.3) | 0 | 1 (4.3) |
| Abdominal discomfort, n (%) | 6 (10.5) | 6 (5.7) | 1 (2.1) | 2 (6.9) | 6 (10.2) | 3 (2.8) | 6 (14.0) | 0 | 0 | 0 | 0 | 0 |
| Severe or BG‐confirmed symptomatic hypoglycemia † , n (%) | 1 (1.8) | 1 (1.0) | 1 (2.1) | 0 | 2 (3.4) | 1 (0.9) | 2 (4.7) | 1 (3.3) | 1 (3.4) | 0 | 0 | 1 (4.3) |
Data from safety analysis set; percentages are based on the n for that subgroup; action taken to trial product was not collected for the additional oral antidiabetes drug (OAD) group, as the additional OAD was not considered as a trial product in this trial.
AE, adverse event; BMI, body mass index; GI, gastrointestinal; E, number of events; N, number of participants in specified subgroup in the safety analysis set; n, number of participants experiencing at least one event; N/A, not applicable; OW, once weekly; R, event rate per 100 years of treatment exposure.
†
An episode that is severe according to the American Diabetes Association (ADA) classification or blood glucose (BG)‐confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycemia.