Efficacy of Russian insulin biosimilars for type 1 diabetes in adolescents

RMZh Mat'' i ditia Pub Date : 2022-01-01 DOI:10.32364/2618-8430-2022-5-2-164-168

V. V. Platonov, T. A. Dubinina, E. Patrakeeva, Alexander P Rezvykh, N. V. Kazachenko

{"title":"Efficacy of Russian insulin biosimilars for type 1 diabetes in adolescents","authors":"V. V. Platonov, T. A. Dubinina, E. Patrakeeva, Alexander P Rezvykh, N. V. Kazachenko","doi":"10.32364/2618-8430-2022-5-2-164-168","DOIUrl":null,"url":null,"abstract":"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):165–168 (in Russ.). DOI: 10.32364/2618-8430-2022-5-2-165-168.","PeriodicalId":34075,"journal":{"name":"RMZh Mat'' i ditia","volume":"1 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"RMZh Mat'' i ditia","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.32364/2618-8430-2022-5-2-164-168","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}

引用次数: 1

Abstract

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):165–168 (in Russ.). DOI: 10.32364/2618-8430-2022-5-2-165-168.

查看原文本刊更多论文

俄罗斯胰岛素生物仿制药治疗青少年1型糖尿病的疗效

目的:评估从原胰岛素(利斯普罗和甘精)转向俄罗斯生物仿制药对青少年1型糖尿病(T1D)血糖控制的潜在影响。患者和方法:这项为期24周的观察性临床试验招募了24名12-15岁的T1D青少年(平均年龄13.4±1.1岁)，13名男孩(54.2%，平均年龄13.1±1.1岁)和11名女孩(45.8%，平均年龄13.0±0.9岁)。男孩病程4.0±1.1年，女孩病程4.3±1.8年。胰岛素治疗包括原每日多次注射胰岛素(MDI)利斯普罗和甘精。患者以1:1的比例切换到生物仿制药，剂量由患者自己调整。采用瞬时血糖监测(FGM)法测定血糖水平。评估原胰岛素治疗中处于目标范围的时间(TIR)、高于目标范围的时间(TAR)、低于目标范围的时间(TBR)和糖化血红蛋白(HbA1c)，以及切换到俄罗斯生物仿制药后的3个月和6个月。结果:T1D青少年改用俄罗斯生物类似药3、6个月后，血糖控制参数无明显恶化，HbA1c(3个月)7.6±1.1%，HbA1c(6个月)7.5±0.9% (p>0.05)， TIR(3个月)65.1±10.6%，TIR(6个月)66.5±10.7% (p>0.05)， TAR(3个月)26.8±10.9%，TAR(6个月)25.5±11.1% (p>0.05)， TBR(3个月)8.1±4.3%，TBR(6个月)7.9±4.5% (p>，05)。在治疗转换后3和6个月，男孩和女孩之间所研究的参数没有显著差异。每日总胰岛素剂量(TDI)无明显变化，TDI(3个月)为1.4±0.3 U/kg, TDI(6个月)为1.3±0.3 U/kg。结论:俄罗斯用于治疗青少年T1D的胰岛素利斯pro和甘精生物仿制药与TDI升高或血糖控制参数(如HbA1c、TIR、TAR和TBR)恶化无关。关键词:1型糖尿病，胰岛素，生物仿制药，利斯普罗，甘精，糖化血红蛋白，血糖控制，时间范围。引证:Platonov v.v.， Dubinina t.a.， Patrakeeva E.M.等。俄罗斯胰岛素生物仿制药治疗青少年1型糖尿病的疗效。俄罗斯妇女与儿童健康杂志，2022;5(2):165-168。DOI: 10.32364 / 2618-8430-2022-5-2-165-168。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊