Abstract

To implement in 2009-2012 the RESULT observational program on the use of insulin glargine (Lantus) in combination with insulin glulisine (Apidra) as a basal-bolus regimen in patients with type 1 diabetes mellitus (DM) to evaluate the efficiency and safety of therapy with human insulin analogues. The program covered 100 patients aged 19 to 25 years from 7 regions of the Russian Federation, who had had DM onset at the age of 9-13 years, were using human recombinant insulins as continuous insulin therapy, and had glycated hemoglobin (HbA1c) levels of 7 to 9%. The main inclusion criterion was switching to insulin therapy with the human insulin analogues Lantus and Apidra. A total 41 men and 59 women were followed up. Their mean baseline HbA1c level was 8.3±0.7%. After 24 months of therapy, HbA1c was significantly decreased to 7.7±0.7%; its change compared with that at Visit 1 was -0.6±0.6% (p<0.001). There was a significant reduction in fasting and postprandial blood glucose levels at 3 months of a follow-up. The number of symptomatic and asymptomatic glycemic episodes declined. No nocturnal or severe hypoglycemic episodes were recorded at 24 months of therapy. Microvascular complications did not progress during the follow-up. The use of human insulin analogues is effective and safe in treating young diabetic patients, improves their quality of life and confers no risk of asymptomatic or nocturnal hypoglycemic states.

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