Table 2.
Summary of adverse events
| 24 weeks | 52 weeks | |||
|---|---|---|---|---|
| Linagliptin | Placebo | Linagliptin | Placebo | |
| Patients (treated seta) | 52 | 50 | 52 | 50 |
| Any AE | 35 (67.3) | 27 (54.0) | 47 (90.4) | 38 (76.0) |
| Severe AE | 4 (7.7) | 3 (6.0) | 8 (15.4) | 5 (10.0) |
| Drug-related AE (investigator-defined) | 14 (26.9) | 4 (8.0) | 14 (26.9) | 10 (20.0) |
| AE leading to discontinuation | 4 (7.7) | 3 (6.0) | 7 (13.5) | 5 (10.0) |
| Serious AEb | 8 (15.4) | 5 (10.0) | 13 (25.0) | 7 (14.0) |
| AEs with > 2% incidence | 35 (67.3) | 27 (54.0) | 47 (90.4) | 38 (76.0) |
| Ear and labyrinth disorders | 0 (0.0) | 0 (0.0) | 2 (3.8) | 0 (0.0) |
| Eye disorders | 4 (7.7) | 0 (0.0) | 5 (9.6) | 2 (4.0) |
| Gastrointestinal disorders | 9 (17.3) | 1 (2.0) | 11 (21.2) | 2 (4.0) |
| Infections and infestations | 11 (21.2) | 4 (8.0) | 22 (42.3) | 9 (18.0) |
| Investigations | 1 (1.9) | 3 (6.0) | 3 (5.8) | 5 (10.0) |
| Metabolism and nutrition disorders | 17 (32.7) | 9 (18.0) | 21 (40.4) | 16 (32.0) |
| Diabetes mellitus | 0 (0.0) | 1 (2.0) | 0 (0.0) | 2 (4.0) |
| Hypoglycaemia | 16 (30.8) | 8 (16.0) | 20 (38.5) | 14 (28.0) |
| Musculoskeletal and connective tissue disorders | 2 (3.8) | 6 (12.0) | 8 (15.4) | 8 (16.0) |
| Reproductive system and breast disorders | 3 (5.8) | 0 (0.0) | 3 (5.8) | 0 (0.0) |
| Skin and subcutaneous tissue disorders | 4 (7.7) | 3 (6.0) | 7 (13.5) | 5 (10.0) |
| Vascular disorders | 0 (0.0) | 1 (2.0) | 2 (3.8) | 1 (2.0) |
| Hypertension | 0 (0.0) | 1 (2.0) | 2 (3.8) | 1 (2.0) |
| AEs of special interest | ||||
| Hypersensitivity reactions | 3 (5.8) | 1 (2.0) | 5 (9.6) | 1 (2.0) |
| Dermatitis allergic | 0 (0.0) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Dermatitis contact | 2 (3.8) | 0 (0.0) | 2 (3.8) | 0 (0.0) |
| Eczema | 0 (0.0) | 0 (0.0) | 2 (3.8) | 0 (0.0) |
| Rash | 0 (0.0) | 1 (2.0) | 0 (0.0) | 1 (2.0) |
| Urticaria | 1 (1.9) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Skin lesions | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Hepatic events | 1 (1.9) | 0 (0.0) | 2 (3.8) | 1 (2.0) |
| Alanine aminotransferase increased | 0 (0.0) | 0 (0.0) | 1 (1.9) | 1 (2.0) |
| Hepatic steatosis | 1 (1.9) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Renal AEs | 1 (1.9) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Renal impairment | 1 (1.9) | 0 (0.0) | 1 (1.9) | 0 (0.0) |
| Pancreatitis | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Pancreatic cancer | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
AE adverse event
aAll patients who were treated with ≥ 1 dose of study medication
bA patient may be counted in > 1 seriousness criterion