: The study population comprised 122 and 89 patients with moderate RI and 94 and 64 patients with severe RI randomized to
vildagliptin and placebo, respectively, with the majority of patients receiving background insulin therapy (72% and 82% for moderate and
severe RI, respectively). After 1 year, the between-treatment difference in adjusted mean change in A1C was −0.4 ± 0.2% (p = 0.005) in
moderate RI (baseline = 7.8%) and −0.7 ± 0.2% (p < 0.0001) in severe RI (baseline = 7.6%). In patients with moderate RI, similar proportions
of patients experienced any adverse event (AE) (84 vs. 85%), any serious adverse event (SAE) (21 vs. 19%), any AE leading to discontinuation
(5% vs. 6%) and death (1% vs. 0%) with vildagliptin and placebo, respectively. This was also true for patients with severe RI: AEs (85% vs.
88%), SAEs (25% vs. 25%), AEs leading to discontinuation (10% vs. 6%) and death (3% vs. 2%).