A total of 316 patients , with type 2 diabetes diagnosed for 12months and with glycated haemoglobin ( HbA1c ) concentration in the range 8.5-12 .0 % , were randomized 1:1 to double-blind , free-combination treatment with linagliptin 5mg once daily and metformin twice daily ( uptitrated to 2000mg/day maximum ) or to linagliptin monotherapy .