OBJECTIVES: To assess the characteristics of type 2 diabetes patients treated with vildagliptin (a new DPP-4 inhibitor) and to evaluate potential misuse, treatment adherence, effectiveness and tolerability of vildagliptin under real-life conditions of care in France. METHODS: Following a request by the French Health Technology Agency (Haute Autorité de Santé) an observational cohort study was started in 2010. The study population included a representative sample of patients with type 2 diabetes initiating a treatment with vildagliptin. Patients were enrolled through a national sample of vildagliptin prescribers Data collected included sociodemographic characteristics, clinical history, comorbidities, detailed treatment and laboratory data, physical exam and adherence. RESULTS: Overall, 482 GPs and 84 endocrinologists enrolled 1702 patients. Sixty percent were males, mean age was 63 (±11) years, mean disease duration was 7 (±6.5) years and mean HbA1C 7.8% (±1.2). Forty-five percent were obese and 39% overweight, 70% were treated for hypertension and 66% for dyslipidaemia, and 1256 patients (74%) were treated with vildagliptin/metformin fixed combination (Eucreas, FC) and 442 (26%) with vildagliptin (Galvus). Main reasons for initiating vildagliptin were: previous treatment failure (82%), weight gain (17%), reducing the numbers of pills (16%) and intolerance to a previous treatment (12%). In accordance to the precautions of use, 1366 patients (80%) underwent liver function tests, and 1552 patients (91%) blood creatinine measurement prior to treatment initiation. In few cases, vildagliptin was prescribed to patients for whom the product was not recommended: at baseline, 2.1% of treated patients presented elevations in alanine/aspartate aminotransferase > 3 times the upper limit of normal, 0.3% a NYHA class III congestive heart failure (no class IV) and 9.3% did not respect the precautions of use for renal function. CONCLUSIONS: Most prescriptions of vildagliptin were in accordance with the summary of product characteristics in this large, randomly selected French population.