Table 5.

Investigator-defined hypoglycaemia (treated set)

	Linagliptin	Placebo
Patients*, n	183	89
Hypoglycaemic adverse events, n (%)	10 (5.5)	5 (5.6)
Any documented symptomatic hypoglycaemia† and measured plasma glucose ≤ 70 mg/dl	2 (1.1)	3 (3.4)
Any documented symptomatic hypoglycaemia‡ and measured plasma glucose < 54 mg/dl	1 (0.5)	2 (2.2)
Any severe hypoglycaemic episode§	0 (0.0)	0 (0.0)

^*All patients who were treated with ≥ 1 dose of study medication.

^†Accompanied by typical symptoms of hypoglycaemia.

^‡Accompanied by typical symptoms of hypoglycaemia but no need for external assistance.

^§Requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions.