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Charles Saab,1 Feryal A Al-Saber,2 Jihad Haddad,3 Mahir Khalil Jallo,4 Habib Steitieh,5 Giovanni Bader,6 Mohamed Ibrahim,7 1Department of Endocrinology and Metabolism, Sacre Coeur University Hospital, Baabda, Lebanon; 2Endocrine Department, Bahrain Defence Force Hospital, Rifaa, Bahrain; 3Division of Endocrinology Department of Internal Medicine, Prince Hamaza Hospital, Amman, Jordan; 4Department of Internal Medicine, Gulf Medical University, Ajman, United Arab Emirates; 5New Mowasat Hospital, Safat, Kuwait; 6Novartis Pharma AG, Basel, Switzerland; 7Novartis Pharma Services AG, Dubai, United Arab Emirates Background: Type 2 diabetes mellitus (T2DM) is a chronic progressive disease that requires treatment intensification with antihyperglycemic agents due to progressive deterioration of β-cell function. A large observational study of 45,868 patients with T2DM across 27 countries (EDGE) assessed the effectiveness and safety of vildagliptin as add-on to other oral antidiabetic drugs (OADs) versus other comparator OAD combinations. Here, we present results from the Middle East countries (Bahrain, Jordan, Kuwait, Lebanon, Oman, Palestine, and the United Arab Emirates). Methods: Patients inadequately controlled with OAD monotherapy were eligible after the add-on treatment was chosen by the physician based on clinical judgment and patient need. Patients were assigned to either vildagliptin or comparator OADs (sulfonylureas, thiazolidinediones, glinides, α-glucosidase inhibitors, or metformin, except incretin-based therapies) based on the add-on therapy. The primary endpoint was the proportion of patients achieving a glycated hemoglobin (HbA1c) reduction of >0.3% without peripheral edema, hypoglycemia, discontinuation due to a gastrointestinal event, or weight gain ≥5%. One of the secondary endpoints was the proportion of patients achieving HbA1c