The most frequently reported adverse reaction was hypoglycaemia observed under the triple combination, linagliptin plus metformin plus sulphonylurea 14.6% versus 7.6% in placebo. In the placebo-controlled studies 6.2% of patients experienced hypoglycaemia as an adverse reaction under linagliptin. Of these, 5.1% were mild and 1.0% were moderate and 0.1% were classified as severe. Pancreatitis was reported more often in patients randomized to linagliptin.