Real-life safety and efficacy of vildagliptin as add-on to metformin in patients with type 2 diabetes in Turkey - GALATA study

PubMed ID: 25697921Objective: To evaluate tolerability/safety and the efficacy of the combination of vildagliptin plus metformin in a real-life population of patients with type 2 diabetes mellitus (T2DM). Research design and methods: This multicenter, single-arm, 6 month, observational, prospective cohort study was conducted at 39 centers across Turkey. T2DM patients on vildagliptin and metformin for ?4 weeks were enrolled regardless of their previous antidiabetic therapy. Main outcome measures: Efficacy was evaluated by measuring hemoglobin A1c (HbA1c) levels. Tolerability/safety parameters evaluated included hypoglycemic events, gastrointestinal events, peripheral edema and weight gain. Results: This study enrolled 665 patients with a mean±standard deviation (SD) age of 55.1±10.2 years and female predominance (n=394, 59.2%). Safety was assessed in all enrolled patients. Hypoglycemia was reported in 10 (1.5%) patients (95% confidence interval = 0.8-2.7%). Efficacy was assessed in 289 (43.5%) patients treated for 6±1 months; these patients showed a mean decrease in HbA1c of 0.8% from baseline value of 7.8% (p65 years) and body mass index (<30 vs. ?30 kg/m2) (p