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B. Buturović, L. Ristic, Alma Mujanovic Narancic

ABSTRACT Introduction: Patient-oriented therapy represents a modern approach in the treatment of patients with diabetes, an approach which is supported in the most recent guidelines by the ADA and the European Association for the Study of Diabetes (EASD). The progressive nature of diabetes demands the introduction of insulin therapy much earlier in order to prevent the development of late complications of the disease. Material and methods: The study included 30 patients who had been treated with long-acting insulin analogue and metformin in doses of 3 x 850 mg at least 6 months prior to study entry and in which a good glycaemic control had not been achieved, or with HbA1c > 7%. Patients who had a BMI > 28 kg /m2 were included in the study. Results and discussion: At the beginning of the study the patients were switched to combined therapy with long-acting basal analog, metformin and liraglutide in a dosage of 0.6 mg of 1x1. After 12 weeks of the new therapeutic regimen we recorded a significant reduction in the parameter levels that we monitored in the study. BMI value after the test was 28.2±1.39 kg/m2, p=0.025, HbA1c 7.24±0.47%, p=0.030, fasting blood glucose level 7.04±0.32 mmol/l, p=0.023, postprandial glucose level 7.6±0.46 mmol/l, p=0.012, systolic blood pressure level 123±5.75 mmHg, p=0.015, diastolic blood pressure level 79.1±2.91 mmHg, p=0.03. During research that we have conducted over 12 weeks, a reduction of body weight was achieved while improving the value of parameters significant for the study. Conclusion: There was a significant lowering of HbA1c, fasting blood glucose levels, postprandial glucose levels and better blood pressure control by which we have proved that GLP1 analogues in combination with basal insulin and metformin provide a good glycaemic control with a cardio protective effect, and reduce the risk of late complications.

B. Buturović, A. Lekic, N. Grulovic

OBJECTIVES 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. DESIGN 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). CONCLUSION 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.

Combination of insulin and metformin has been shown to improve glycaemic control in clinical trials, particularly in obese patients with diabetes type 2. Insulin therapy can improve function of pancreatic beta cells and periphery insulin activity in target cells in order to enhance glycaemic homeostasis (1, 2, 3). In our study we included obese patients with diabetes type 2 in the early stage of the disease. The study is partially retrospective and partially prospective. The study encompassed 40 patients split in two groups. The first group of 20 patients received insulin therapy combined with metformin, while the patients of the second group were treated with oral antidiabetic drugs, sulfonylureas and metformin. Three months later, the group treated with insulin and metformin showed improvement in the monitored parameters, namely significant reduction in HbA1c (p = 0.003), MFBG (p = 0.0009), PPG (p = 0.028). Insulin therapy administered together with metformin, in obese patients with diabetes type 2, in the early stage of the disease, resulted in well regulated fasting blood glycaemia, as well as post challenge glycaemia and HbA1c.

B. Heljić, Z. Velija-Ašimi, Azra Bureković, B. Buturović, Armana Cerić, Bosanko Horozić, D. Sakambet, Amela Dizdarević-Bostandžić et al.

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.

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