LOTUS2: The observational study of the effectiveness and safety of insulin glargine (lantus) in the routine clinical practice for the patients with type 2 diabetes mellitus failing to achieve the targeted glycemic control using insulin detemir
https://doi.org/10.14341/probl201359525-31
Abstract
The present study included patients presenting with type 2 diabetes mellitus (DM2) of less than 10 years in duration having the HbA1c levels between 7.0% and 10.0%. They were treated with insulin detemir (once or twice daily) in combination with oral hypoglycemic agents (OHGA) and transferred thereafter to therapy with insulin glargine (Lantus, SoloSTAR) administered once daily. The patients were advised to adjust the dose of insulin glargine in order to achieve the desired fasting blood glucose level (FBGL) below 5.6 mmol/l. The HbA1c levels and FBGL, insulin doses, body weight, frequency of hypoglycemic episodes and adverse reactions were measured within 3 and 6 months after inclusion in the study; simultaneously, the patients and doctors' satisfaction with the treatment was estimated. A total of 915 patients were available for the examination (mean age 57.9±9.2 years, mean duration of DM2 5.9±2.3 years, average BMI 31.0±5.1 kg/m2). The number of the patients presenting with the HbA1c levels below 7% within 6 months after the onset of therapy amounted to 46.5% of the total. During the same period, percentage of the patients experiencing nocturnal and daytime glycemic episodes decreased. No cases of severe hypoglycemia were documented. Moreover, the body weight of the patients somewhat decreased (by 0.9±2.9 kg; p<0.001) by the 6 month. The majority of the patients and their doctors reported the effects of described therapy as "good" or "very good". It is concluded that the substitution of the treatment with insulin detemir in combination with OHGA by therapy with insulin glargine in the patients with DM2 and suboptimal glycemic control under conditions of the routine clinical practice may improve the quality of glycemic control without a substantial body weight gain and with the low frequency of hypoglycemic episodes.
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For citations:
Glinkina I.V. LOTUS2: The observational study of the effectiveness and safety of insulin glargine (lantus) in the routine clinical practice for the patients with type 2 diabetes mellitus failing to achieve the targeted glycemic control using insulin detemir. Problems of Endocrinology. 2013;59(5):25-31. (In Russ.) https://doi.org/10.14341/probl201359525-31
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