[LEAP (Lantus Early Access Programme) in Sarajevo].
LEAP is multicentric study in phase IV. The first aim was to affirm Lantus efficacy and safety in every day practice, in local conditions. The second aims were to verify therapy successful by measuring fast blood glucose (FBG) and HbA1c and to estimate patients' pleasure. Duration of study was 2 months. Lantus was administrated subcutaneously daily. Doses were individual. HbA1c was measured at the begining of therapy and at the last control. Blood glucose was measured every day. The study included patients who did not reach the control of glycemy, or patients with frequent hypoglycemic crysis, older then 6 year. LEAP study in Sarajevo included 114 patients. Fifty four patients (47%) were men, and 60 (53%) were women. 46% diabetics have type 1 of diabetes mellitus and 54% have type 2 diabetes mellitus. The results of study demonstrated statistically significant decreasing of FBG and HbA1c in both groups (I group--patients younger than 18 years and II group--patients older than 18 years), p<0.05. FBG in I group on the start of Lantus therapy was 9.9+/-3.9 mmol/l but on ending control was 8.7+/-4.4 mmol/l (p<0.05). HbA1c on start of therapy was 9.4+/-1.9%, but on end control was 8.0+/-1.8% (p<0.05). FBG in II group on start was 13.6+/-4.7 mmol/l but on finish was 7.3+/-2.9 mmol/l (p<0.01). HbA1c on start was 9.3+/-1.8% and on end was 7.2+/-1.2% (p<0.01). These results showed that the Lantus is very efficacious for good glycoregulation. Just for two months, HbA1c decreased for 2%. Undesirable effects were not registered. We concluded that Lantus is very safe. Most patients (89%) were satisfied with therapy.