Efficacy of Russian insulin biosimilars for type 1 diabetes in adolescents

Abstract

V.V. Platonov1,2, T.A. Dubinina1, E.M. Patrakeeva3, A.M. Rezvykh2, N.V. Kazachenko1 1K.A. Raukhfus Children’s City Multidisciplinary Clinical Center of High Medical Technologies,    St. Peterburg, Russian Federation 2St. Petersburg State Pediatric Medical University, St. Petersburg, Russian Federation 3Dr. Fomin’s Clinics in St. Petersburg, St. Petersburg, Russian Federation Aim: to assess the potential effect of switching from original insulins (lispro and glargine) to Russian biosimilars on glycemic control in adolescents with type 1 diabetes (T1D). Patients and Methods: this 24-week observational clinical trial enrolled 24 adolescents with T1D aged 12–15 (mean age 13.4±1.1 years), 13 boys (54.2%, mean age 13.1±1.1 years) and 11 girls (45.8%, mean age 13.0±0.9 years). Disease duration was 4.0±1.1 years in boys and 4.3±1.8 years in girls. Insulin therapy included original multiple daily injections (MDI) of insulins lispro and glargine. Patients were switched to biosimilars at a ratio of 1:1, doses were adjusted by the patients themselves. Blood sugar levels were measured by flash glucose monitoring (FGM). Time in the target range (TIR), time above the target range (TAR), time below the target range (TBR), and glycated hemoglobin (HbA1c) in the original insulin therapy and 3 and 6 months after switching to Russian biosimilars were evaluated. Results: three and six months after switching of T1D adolescents to Russian biosimilars, no clinically significant worsening of glycemic control parameters was reported, i.e., HbA1c (3 months) 7.6±1.1%, HbA1c (6 months) 7.5±0.9% (p>0.05), TIR (3 months) 65.1±10.6%, TIR (6 months) 66.5±10.7% (р>0.05), TAR (3 months) 26.8±10.9%, TAR (6 months) 25.5±11.1% (p>0.05), TBR (3 months) 8.1±4.3%, TBR (6 months) 7.9±4.5% (p>0,05). No significant differences in the parameters studied between boys and girls 3 and 6 months after therapy switching were reported. No significant changes in the total daily Insulin dose (TDI) were reported, i.e., TDI (3 months) 1.4±0.3 U/kg, TDI (6 months) 1.3±0.3 U/kg. Conclusion: Russian biosimilars of insulins lispro and glargine for T1D in adolescents are not associated with either an increase in TDI or worsening of glycemic control parameters, e.g., HbA1c, TIR, TAR, and TBR. Keywords: type 1 diabetes, insulin, biosimilars, lispro, glargine, glycated hemoglobin, glycemic control, time in the range. For citation: Platonov V.V., Dubinina T.A., Patrakeeva E.M. et al. Efficacy of Russian insulin biosimilars for type 1 diabetes in adolescents. Russian Journal of Woman and Child Health. 2022;5(2):164–168 (in Russ.). DOI: 10.32364/2618-8430-2022-5-2-164-168.