Table 4.
Summary of adverse events (treated set)
| Study 1 | Study 2 | |||||
|---|---|---|---|---|---|---|
| Japanese* 12 weeks | Asian 24 weeks | White 24 weeks | ||||
| Linagliptin n = 159 | Placebo n = 80 | Linagliptin n = 156 | Placebo n = 76 | Linagliptin n = 180 | Placebo n = 90 | |
| Any AE, n (%) | 89 (56.0) | 45 (56.3) | 89 (57.1) | 43 (56.6) | 95 (52.8) | 55 (61.1) |
| Drug‐related AEs, n (%) | 15 (9.4) | 8 (10.0) | 10 (6.4) | 5 (6.6) | 10 (5.6) | 2 (2.2) |
| AEs leading to discontinuation of trial medication, n (%) | 3 (1.9) | 7 (8.8) | 1 (0.6) | 2 (2.6) | 4 (2.2) | 3 (3.3) |
| Serious AEs, n (%) | 1 (0.6) | 1 (1.3) | 3 (1.9) | 3 (3.9) | 7 (3.9) | 5 (5.6) |
| AEs occurring in >5% of patients†, n (%) | ||||||
| Constipation | 9 (5.7) | 5 (6.3) | 4 (2.6) | 1 (1.3) | 0 | 0 |
| Dyslipidemia | – | – | 5 (3.2) | 4 (5.3) | 1 (0.6) | 1 (1.1) |
| Upper respiratory tract infection | 2 (1.3) | 0 | 9 (5.8) | 7 (9.2) | 0 | 0 |
| Nasopharyngitis | 26 (16.4) | 10 (12.5) | 3 (1.9) | 0 | 10 (5.6) | 7 (7.8) |
| Hyperglycemia | 1 (0.6) | 3 (3.8) | 10 (6.4) | 9 (11.8) | 23 (12.8) | 29 (32.2) |
Study 1: Medical Dictionary for Regulatory Activities (MedDRA) version 12.112; study 2: MedDRA version 14.011. *Previously reported by Kawamori et al.12 †A frequency cut‐off of >5% in either treatment group at the preferred term level. AE, adverse event.