Patients, n (%) | Omarigliptin N = 153 | Placebo N = 153 | Differencea |
---|---|---|---|
With one or more | |||
AEs | 88 (57.5) | 43 (47.7) | 9.8 (−1.4, 20.8) |
Drug-relatedb AEs | 12 (7.8) | 10 (6.5) | 1.3 (−4.8, 7.5) |
Serious AEs | 3 (2.0) | 5 (3.3) | −1.3 (−5.7, 2.8) |
Serious drug-relatedb AEs | 2 (1.3) | 0 (0.0) | 1.3 |
Who died | 0 (0.0) | 0 (0.0) | 0.0 |
Who discontinued due to | |||
An AE | 4 (2.6) | 4 (2.6) | 0.0 (−4.3, 4.3) |
A drug-relatedb AE | 2 (1.3) | 1 (0.7) | 0.7 |
A serious AE | 0 (0.0) | 1 (0.7) | −0.7 |
A serious drug-relatedb AE | 0 (0.0) | 0 (0.0) | 0.0 |
With one or more AE of hypoglycemia | 18 (11.8) | 13 (8.5) | 3.3 (−3.6, 10.3) |
Symptomaticc | 16 (10.5) | 13 (8.5) | 2.0f (−4.8, 8.8) |
Severed | 5 (3.3) | 1 (0.7) | 2.6 (−0.7, 6.9) |
Asymptomatice | 2 (1.3) | 0 (0.0) | 1.3 |