The study recruited 2,789 patients who were inadequately controlled on metformin monotherapy. Participants were then randomised to vildagliptin 50mg twice daily or glimepiride titrated up to 6mg daily. These results are a prespecified interim analysis after 52 weeks to ensure that vildagliptin is non-inferior to glimepiride.
Baseline HbA1c was 7.3% in both groups. This fell by 0.44% in the vildagliptin arm and 0.53% in the glimepiride arm. The difference was not significant and therefore non-inferiority was proven.
Other notable differences reported include a lower incidence of hypoglycaemia in the patients receiving vildagliptin and beneficial effects on body weight. Patients treated with vildagliptin lost approximated 0.23kg compared to a weight gain of 1.56kg in the glimepiride cohort. Additionally, no major differences were noted in haematological or biochemical parameters. This provides some reassurance with respect to the liver enzyme elevations that delayed the drugs launch however patients with clinically significant liver disease or abnormal liver enzyme results at screening were excluded from this study.
Action: These results start to build an evidence base for vildagliptin. Clinicians should await the NICE guidance on newer agents for type 2 diabetes due later this month before changing practice.