The second CV outcome study, CARdiovascular Safety & Clinical outcoME with LINAgliptin (CARMELINA®), will compare the CV and renal safety of linagliptin versus placebo, when added to standard care in approximately 8300 patients with T2DM at high CV and renal compromise, and is the only large outcome study dedicated to the evaluation of tangible renal outcomes with a DPP-4 inhibitor in comparison with placebo. This evidence concerns the gene DPP4 and type 2 diabetes mellitus.