Table 3.
Adverse events summary
| Omarigliptin | Sitagliptin | ||
|---|---|---|---|
| Subjects, n (%) | N = 322 | N = 320 | Difference 1 |
| With one or more | |||
| AEs | 117 (36.3) | 130 (40.6) | −4.3 (−11.8, 3.2) |
| Drug‐related2 AEs | 12 (3.7) | 12 (3.8) | 0.0 (−3.2, 3.1) |
| Serious AEs | 11 (3.4) | 9 (2.8) | 0.6 (−2.3, 3.5) |
| Serious drug‐related2 AEs | 0 (0.0) | 0 (0.0) | 0.0 |
| Who died | 0 (0.0) | 1 (0.3) | −0.3 |
| Who discontinued due to | |||
| An AE | 3 (0.9) | 7 (2.2) | −1.3 (−3.6, 0.8) |
| A drug‐related2 AE | 0 (0.0) | 1 (0.3) | −0.3 |
| A serious AE | 1 (0.3) | 2 (0.6) | −0.3 |
| A serious drug‐related2 AE | 0 (0.0) | 0 (0.0) | 0.0 |
| With one or more AE of hypoglycaemia | 12 (3.7) | 15 (4.7) | −1.0 (−4.3, 2.3) |
| Symptomatic3 | 10 (3.1) | 13 (4.1) | −1.0 (−4.1, 2.1)4 |
| Asymptomatic5 | 5 (1.6) | 3 (0.9) | 0.6 (−1.4, 2.8) |
1
Difference in % vs sitagliptin; estimate (95% CI) was computed only for those endpoints with at least 4 patients having events in ≥1 treatment groups.
2
Assessed by the investigator as related to study drug.
3
Symptomatic hypoglycaemia: episode with clinical symptoms attributed to hypoglycaemia, without regard to glucose level.
4
P = .515.
5
Asymptomatic hypoglycaemia: glucose values ≤3.9 mmol/L without symptoms.