This licence change is based on the results of a prospective 24-week double-blind study in 515 patients with renal impairment. Participants were randomised to receive vildagliptin or placebo, in addition to their existing antidiabetic therapy. Researchers found that the safety profile of vildagliptin was similar to that of placebo but vildagliptin provided a statistically and clinically significant reduction in HbA1C levels compared with placebo.
The combination product Eucreas (vildagliptin + metformin) remains contraindicated in patients with creatinine clearance <60ml/min because of the metformin component.
View Galvus drug record
View Eucreas drug record
Further information: Novartis