Background: The incidence of Type 2 diabetes (T2D) in children and adolescents is rising globally and parallels the rise in childhood obesity prevalence. Until 2019, metformin and insulin were the only approved treatment options for T2D management in adolescents. Add-on therapies are recommended when treatment targets are not met. The evidence of using IDegLira fixed-ratio combination in children and adolescents is lacking. Aim: This study aims to assess the efficacy of off label use of IDegLira in Emirati adolescents. Method: The electronic medical records of all children and adolescents with T2D who were on IDegLira once daily were reviewed retrospectively, between January 2018 and December 2020. All patients who received IDegLira for at least 16 weeks were included. Anthropometric data, metabolic parameters, diabetes treatments and the total daily dose of insulin were recorded. Post initiation values at 16 weeks were compared against the baseline values using Paired t-test and Wilcoxon signed rank test. Mean (SD) are presented for normally distributed measures, median (IQR) for non-parametric distribution. Results: Fifteen patients [8 females, mean (SD) age 16.5 (1.9) years, weight 92.9 (17.2) kg] with T2D [duration 3.8 (1.8) years] were identified. 13 patients were on Metformin and 14 on multiple daily injections of insulin (MDI) at baseline. At 16 weeks (n = 13), HbA1c decreased by 1.1% [10.7 (1.9)% vs 9.4 (1.7)%, p = 0.017]. The change in total daily dose of insulin per kg body weight/day [0.98 (0.1) units vs 0.86 (0.1) units, p = 0.241], and weight [92.9 (17.2) kg vs 93.0 (18.2) kg, p= 0.017] at 16 weeks were not statistically significant. The combination therapy proved to be well tolerated. Table 1. Difference in metabolic parameters between baseline and 3-4 months in adolescents (12-19 years), with type 2 diabetes.Tabled 1Metabolic ParametersBaseline Mean (SD)3-4 months Mean (SD)P-valueN1313HbA1c, %10.7 (1.9)9.4 (1.7)0.017Weight, kg92.9 (17.2)93.0 (18.2)0.872Total daily dose of insulin, units89.6 (10.3)75.7 (7.7)0.19Insulin requirement, units/kg body weight/day0.98 (0.1)0.86 (0.1)0.241Median (IQR)Median (IQR)TC, mmol/L4.6 (4.4, 5.0)4.5 (4.1, 5.1)0.600TG, mmol/L2.0 (1.0, 2.1)1.8 (1.2, 2.0)0.421HDL-c, mmol/L1.0 (0.9, 1.3)0.9 (0.9, 1.2)0.599non-HDL, mmol/L3.4 (3.3, 3.7)3.3 (3.1, 3.9)0.484LDL-c, mmol/L3.3 (3.1, 3.6)3.3 (2.8, 3.9)0.806Insulin (n=12), High density lipoprotein (HDL-c), Low density Lipoprotein (LDL-c), Total cholesterol (TC), Triglycerides (TG). Open table in a new tab Discussion: In a real-world setting, IDegLira achieves improvement in glycaemic control in adolescents with T2D and promotes patient adherence by simplifying insulin regimens. Further larger studies with longer follow-ups are warranted to support the safety and efficacy of these agents in adolescents with T2D. Insulin (n=12), High density lipoprotein (HDL-c), Low density Lipoprotein (LDL-c), Total cholesterol (TC), Triglycerides (TG).
Read full abstract