Table 3.
Overall AEs, hypoglycaemic episodes and common AEs (≥5% in any linagliptin group) – treated set
| % | Normal renal function† | Mild RI† | Moderate RI† | |||
|---|---|---|---|---|---|---|
| Linagliptin 5 mg (n = 886) | Placebo (n = 346) | Linagliptin 5 mg (n = 630) | Placebo (n = 221) | Linagliptin 5 mg (n = 69) | Placebo (n = 25) | |
| Any AE | 58.2 | 58.7 | 59.0 | 57.0 | 66.7 | 60.0 |
| Serious AEs | 2.4 | 4.0 | 3.8 | 2.7 | 5.8 | 4.0 |
| Drug-related AEs | 10.2 | 8.4 | 13.5 | 11.3 | 14.5 | 0 |
| Any investigator-reported hypoglycaemia‡ | 11.1 | 6.9 | 11.9 | 9.0 | 15.9 | 12.0 |
| Severe hypoglycaemia requiring assistance§ | 0.1 | 0.6 | 0.3 | 0 | 2.9 | 0 |
| Common AEs | ||||||
| Cough | 2.1 | 1.4 | 1.9 | 0.9 | 5.8 | 0 |
| Dizziness | 2.4 | 1.4 | 2.4 | 1.4 | 7.2 | 20.0 |
| Hyperglycaemia | 6.4 | 15.3 | 5.4 | 14.0 | 8.7 | 4.0 |
| Nasopharyngitis | 4.9 | 4.6 | 5.1 | 4.1 | 5.8 | 8.0 |
| Upper respiratory tract infection | 4.6 | 6.1 | 3.7 | 5.0 | 4.3 | 12.0 |
AEs, adverse events; RI, renal impairment.
MedDRA version 12.1 used for reporting.
Renal function according to modification of diet in renal disease formula: normal, ≥90 ml/min/1.73 m2; mild, 60–<90 ml/min/1.73 m2; moderate, 30–<60 ml/min/1.73 m2.
Hypoglycaemic episodes were classified by the investigator according to the following definitions:
Asymptomatic hypoglycaemia: event not accompanied by typical symptoms of hypoglycaemia but with a measured plasma glucose concentration of ≤3.9 mmol/l (≤70 mg/dl).Documented symptomatic hypoglycaemia with a measured plasma glucose concentration of ≥3.0 mmol/l (≥54 mg/dl) and ≤3.9 mmol/l (≤70 mg/dl), accompanied by typical symptoms of hypoglycaemia.Documented symptomatic hypoglycaemia with a measured plasma glucose concentration of <3.0 mmol/l (<54 mg/dl), accompanied by typical symptoms of hypoglycaemia but no need for external assistance.
Severe hypoglycaemic episode: event requiring assistance of another person to administer carbohydrate, glucagon or other resuscitative actions.