Both drugs were well tolerated. The incidence of
hypoglycaemia was similar between the two treatment groups
(16% vs 15%). These incidences are low given the vulnerable
patient population and that the majority of patients were on
insulin treatment. In a study with a similar design, the rates of
hypoglycaemia in vildagliptin-treated and placebo-treated patients
were of similar magnitude as in our study [11]. The
longer extension of the meal-induced increase in GLP-1 and
GIP with vildagliptin was not associated with a safety concern
in the present study. Of interest, in a prior study in which
vildagliptin was dosed at either 50 mg once daily or 50 mg
twice daily (i.e. double the recommended dose on the global
label) in patients with ESRD, both dosing regimens were well
tolerated [19]. Thus, this and other clinical trials demonstrated
a good safety and tolerability profile of the entire DPP-4 inhibitor
class in populations with severe RI, irrespective of the
degree of renal excretion or catalytic binding kinetics