Multifactorial effects of vildagliptin added to ongoing metformin therapy in patients with type 2 diabetes mellitus

Abstract Background To assess the efficacy of a vildagliptin and metformin combination therapy to a metformin monotherapy in type 2 diabetes mellitus patients. Methods Sixty-one patients with diabetes inadequately controlled by a metformin monotherapy were randomized to treatment with a combination therapy of vildagliptin 100 mg and a metformin versus metformin monotherapy. This was a 12-week randomized parallel group study. During the study we assessed parameters of glycemic and lipid metabolism as well as the treatment effects on the release of proinflammatory and antiinflammatory cytokines. Results Compared with baseline values we observed a significant improvement of glycaemic parameters such as HbA 1c , FPG, PPG, FPI, HOMA-IR and HOMA-β index as well as decrease of TCh, TG and LDL and an increase of HDL with the greatest extent of vildagliptin plus a low-dose metformin therapy group. A metformin combination therapy significantly decreased such inflamation parameters as hs-CRP, ox-LDL, TNF-α and IL-1β levels relative to monotherapies. All treatments were well tolerated and there was no incidence of hypoglycaemia. Conclusions Vildagliptin added to an ongoing metformin therapy allows to achieve better metabolic control parameters in comparison with a metformin monotherapy and the combination treatment is well tolerated and has a low risk of serious adverse effects.