The effectiveness and safety of the supplementation of therapy with oral hypoglycemic agents by basal insulin in the patients with type 2 diabetes mellitus. Results of the SOLOS observational program

The results of numerous clinical investigations carried out during the last years provide convincing evidence of the high effectiveness and safety of early initiation of insulin therapy. Of special interest are the studies conducted under conditions of real clinical practice. One of them is the Russian SOLOS observational program designed to evaluate the influence of intensification of the treatment of type 2 diabetes mellitus with oral hypoglycemic agents (OHA) supplemented by using insulin glargine in the patients who failed to be adequately compensated by OHA therapy alone. Another objective of this program was to find out the opinion of the patients and physicians about the SoloStar pen employed for injecting insulin glargine. The data concerning 1309 patients at the mean age of 59.5±8.8 years with type 2 diabetes mellitus and the mean duration of the disease 6.9±5.0 years were available for the analysis. The overwhelming majority of the patients presented with severe decompensation of carbohydrate metabolism, the mean fasting blood glucose level being 10.7±2.4 mmol/l and the HbA1c level varying from 7.2 to 18.2% (mean 9.6±1.5%). Supplementation of OHA therapy with insulin glargine caused the significant reduction of the HbA1c level to 8.1±1.0% (p<0.001) within 3 months after the onset of the combined treatment. The HbA1c level fell down to 7.2±0.9% (p<0.001) after 6 months 40.6% of the patients had HbA1c at the level below 7%. Fasting blood glucose levels decreased to 7.4±1.4 mmol/l and 6.3±1.0 mmol/l (p<0.001) at 3 and 6 months after the onset of insulin administration respectively. The number of daytime and nocturnal hypoglycemic episodes under effect of insulin glargine injections significantly decreased by the end of the study. Severe hypoglycemic episodes suffered initially by 8 (0.5%) patients totally disappeared 6 months after the initiation of the combined therapy. Most patients did not need hospitalization after supplementation of OHA treatment with insulin. The results of combined therapy with the use of disposable SoloStar pens were positively assessed by the overwhelming majority of both the patients and the physicians involved in the study.

type 2 diabetes mellitus, insulin therapy, real clinical practice, insulin glargine, SoloStar pen

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