On-treatment adverse events
| Patients with at least one event, n (%) | Durability* (weeks 0–104) | Switch† (weeks 52–104) | |
| Oral semaglutide (n=253) | Oral semaglutide (n=100) | Sitagliptin (n=97)‡ | |
| All AEs | 215 (85.0) | 75 (75.0) | 67 (69.1) |
| Severe | 23 (9.1) | 8 (8.0) | 1 (1.0) |
| Moderate | 132 (52.2) | 37 (37.0) | 35 (36.1) |
| Mild | 187 (73.9) | 64 (64.0) | 60 (61.9) |
| SAEs | 36 (14.2) | 9 (9.0) | 7 (7.2) |
| Deaths§ | 0 | 0 | 0 |
| Premature discontinuation of study drug due to AEs | 23 (9.1) | 6 (6.0) | 0 |
| Premature discontinuation of study drug due to gastrointestinal disorder AEs | 15 (5.9) | 4 (4.0) | 0 |
| Most frequent AEs occurring in ≥5% of patients by preferred term (MedDRA V.20.1) | |||
| Nausea | 58 (22.9) | 17 (17.0) | 4 (4.1) |
| Nasopharyngitis | 34 (13.4) | 7 (7.0) | 10 (10.3) |
| Diarrhea | 29 (11.5) | 10 (10.0) | 3 (3.1) |
| Headache | 29 (11.5) | 4 (4.0) | 3 (3.1) |
| Abdominal pain, upper | 20 (7.9) | 6 (6.0) | 1 (1.0) |
| Dyspepsia | 18 (7.1) | 4 (4.0) | 2 (2.1) |
| Vomiting | 18 (7.1) | 7 (7.0) | 2 (2.1) |
| Upper respiratory tract infection | 18 (7.1) | 1 (1.0) | 4 (4.1) |
| Arthralgia | 17 (6.7) | 3 (3.0) | 4 (4.1) |
| Back pain | 17 (6.7) | 3 (3.0) | 5 (5.2) |
| Influenza | 15 (5.9) | 6 (6.0) | 4 (4.1) |
| Gastroenteritis | 13 (5.1) | 3 (3.0) | 0 |
| Constipation | 11 (4.3) | 5 (5.0) | 1 (1.0) |
*Patients randomized to oral semaglutide at baseline (week 0).
†Patients previously randomized to sitagliptin at baseline (week 0) and rerandomized to either oral semaglutide or sitagliptin at the start of the extension phase (week 52).
‡One patient was rerandomized to sitagliptin, but was not exposed to the study drug and was therefore included in the full analysis set for the sitagliptin group (n=98) and excluded from the safety analysis set (n=97).
§In-trial data.
AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities; SAE, serious adverse event.