Background: Type 2 diabetes mellitus (T2DM) is a complex condition characterized by various factors. It may be inferred that a therapy strategy focused on addressing a singular fault is improbable to attain normoglycemia or impede the advancement of the disease and therefore there is need of combination therapy. Objective: To determine the efficacy and safety of linagliptin in initial combination with metformin in patients with T2DM. Methods: This was 1-year randomised, double-blind study in which adults with type 2 diabetes received either metformin 1000 mg bid monotherapy or linagliptin 2.5 mg plus metformin 500 mg bidfor 52 weeks. During the study period mean variation in glycated haemoglobin levels between week 52 and the baseline (primary endpoint) and the average change in fasting blood glucose over time from baseline were measured every 10 weeks. Results: Across all patients who received study drug in the extension, the mean age was 57.3 years, and most patients (71.5%) were younger than 65 years. Serum level of HbA1c and fasting glucose were comparable across treatment groups at baseline. HbA1c and plasma glucose decreased in all groups by the end of the 12-month trial however, the reduction was more significant in the combination treatment group than metformin monotherapy. Effect of treatment was not seen on the patients' weight and waist circumference changes, as well as their use of rescue treatment. Safety profile were comparable across the treatment group. Conclusion: The combination of linagliptin and metformin over a 12-month period maintained the clinically significant improvements in glycaemic control along with comparable safety profile.