OBJECTIVES: Metformin is an established first line treatment for type 2 diabetes mellitus (T2DM) patients but intensification of oral antidiabetic therapy is usually required over time. The Effectiveness of Diabetes control with vildaGliptin and vildagliptin/mEtformin (EDGE) study compared effectiveness and safety of vildagliptin and other oral antidiabetic drugs in 45868 worldwide patients with T2DM inadequately controlled by monotherapy under real life conditions. Here we demonstrate effectiveness results for patients receiving vildagliptin or sulfonylurea (SU) add-on to metformin in Germany.  METHODS: T2DM patients inadequately controlled with current monotherapy are eligible after add-on treatment was chosen by the physician based on patient’s need. Effectiveness was assessed by HbA1c drop and by means of a composite endpoint assessing the proportion of patients responding to treatment (HbA1c  <7.0) without proven hypoglycemic event and without significant weight gain (<5%) after 12 months of treatment.  RESULTS: In total 8887 patients were enrolled in Germany; 5779 patients received metformin+ vildagliptin (4960) or metformin+SU (819). Mean age was 62.6±11.1 years, mean T2DM duration was 5.8±4.9 years. Average BMI was 30.8±5.5 kg/m². Mean baseline HbA1c was comparable (vildagliptin:7.8%; SU:7.7%). After 12 months of treatment, HbA1c decreased in both cohorts (vildagliptin:-0.69%; SU:-0.46%) but the drop was significantly greater with vildagliptin compared to SU (Δ-0.23%; CI95% -0.32   -0.14; p<0.001).  In the vildagliptin cohort, a higher proportion of patients reached the composite endpoint (HbA1c<7, no hypoglycemic events, no weight gain) when compared to the SU cohort (vildagliptin:25.5%; SU:17.7%; p<0.001). The overall recorded number of hypoglycemic events was low (vildagliptin:0.11%; SU:0.41%) but almost 4-fold higher in the SU cohort when compared to the vildagliptin cohort. CONCLUSIONS: In real life clinical practice in Germany, vildagliptin is associated with a greater HbA1c-drop, less hypoglycemic events and a higher proportion of patients reaching target HbA1c without hypoglycemia and weight gain compared to SU.