OBJECTIVE Monitoring efficacy of insulin glargine administered to patients with diabetes mellitus type 2 (DMT2) in combination with rapid-action insulin and analogues, where the hitherto fixed-mixture insulin therapy failed to achieve a satisfactory glycaemic control (HbA1c < 7%) following a six-month fixed-mixture insulin therapy. METHODS Open, observational, multicentric, non comparative, prospective product registry. RESULTS 9-month prospective observational study recruited DMT2 patients previously uncontrolled on premixed insulin (HbA1c > 7%). Total of 278 subjects were documented in the study. At 9 months of follow-up 45,3% of patients reached a target HbA1c level <7% with a mean HbA1c change from 9.63 +/- 1.64% to 7.10 +/- 0.77% (p<0.01). Fasting plasma glucose values decreased from 12.7 +/- 4.3 mmol/L to 6.6 +/- 1.4 mmol/L (p<0,01). 93 patients (33,4%) experienced hypoglycemia events (3(1) hypoglycemic episode). Insulin glargine mean starting dose was 32,4 +/- 11,5 U. This dose was increased progressively over the study visits to a final mean dose of 42,0 +/- 11,9 U (p<0.01). The mean final daily dose of rapid-acting insulin was 24.8 +/- 13.7 U and was almost unchanged during the study. Patients who did not adhere to treatment were 4.9 times more likely to fail to achieve target HbA1c level (RR [95%CI] = 4.9 [1.7-12.11, p<0.01). CONCLUSIONS Results from the study suggest that basal-bolus regimen consisting of insulin glargine significantly improves glycaemic control without increasing hypoglycemia risk in DMT2 population with inadequate glycaemic control on previous premixed therapy.