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The present multi-center non-randomized open prospective phase IV study was carried out based at 8 clinical centers of the Russian Federation. It included 89 patients at the age from 6 to 17 years suffering from type 1 diabetes mellitus during a period over 1 year. The children treated with Lantus (insulin glargin) in combination with any short-acting insulin in accordance with the basal-bolus regime and having the HbA1c level from=>8% to =<10% were transferred to Apidra (insulin glulisine) therapy in combination with Lantus insulin. The number of patients in the first age group (6-12 years) having the HbA1c level <8% within 12 months after the onset of therapy was 51.1%. However, only 31.1% of them, did not experience episodes of symptomatic hypoglycemia during this period with the blood glucose level =< 3.1 mmol/l. In the age group 2 (13-17 years), 31.1% of the patients reached the target HbA1c level <7.5% during the 12 month treatment period, but only 13.3% had no episodes of symptomatic hypoglycemia of =<3.1 mmol/l during this period. The HbA1c level in groups 1 and 2 decreased from 8.75±0.6 to 8.05 ±1.06% (p=0.046658) and from 8.77±0.58 to 7.96±1.12% (p=0.017533) respectively. The requirements for insulin in either group did not significantly change throughout the study period. A total of 1866 hypoglycemic episodes were recorded (i.e. 20.73 episodes per patient) including 90.8% of daytime and 9.2% of nocturnal hypoglycemia; symptomatic hypoglycemia accounted for 98.8% of all the cases and asymptomatic one for 1.2%. Fifty three (0.35%) cases were interpreted as severe hypoglycemia (blood glucose level ≤2 mmol/l), five (0.27%) patients had to be hospitalized . Hypoglycemic episodes were not documented in 13 children.

problemy èndokrinologii

The fifty two week study of the effectiveness and safety of Apidra insulin therapy in combination with Lantus insulin in the children and adolescents with type 1 diabetes mellitus and poor glycemic control