Secondary end points include: the control rate of HbA1c ≤6.5 % and HbA1c <7.0 % in patients who achieve their assigned FPG target; the percentage of patients who achieve HbA1c <7 % without hypoglycemia per FPG target group; reduction in HbA1c, FPG and postprandial glucose (PPG) from baseline (week 1) to week 24; and the mean insulin dose of each FPG group at the end of the treatment period. This evidence concerns the gene INS and Hypoglycemia.