Abasaglar® (insulin glargin): Användning hos Barn

Use of Abasaglar in Paediatric Patients

Abasaglar 100 units/mL solution for injection is indicated for the treatment of diabetes mellitus (DM) in adults, adolescents, and children aged 2 years and above.¹

Abasaglar was not studied in children and adolescents 18 years of age or younger.²

Abasaglar can be used in children age 2 years and above, based on the efficacy and safety of Lantus in studies of children age 2 years and above.²

Clinical study safety data for Abasaglar are not available for children under 2 years of age.²

Clinical and Pharmacokinetic Studies of Insulin Glargine in Paediatric Patients

Several clinical studies have demonstrated the efficacy and safety of IG-100 when used for the treatment of T1DM in paediatric patients.^3-5

In a PK study of IG-100 in 62 children, aged 2 to 6 years, with T1DM, plasma trough concentrations of IG-100 and its main M1 and M2 metabolites

• were similar to those observed in adult patients, and

• provided no evidence for accumulation with chronic dosing.^6,7

References

1. Abasaglar [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

3. Danne T, Philotheou A, Goldman D, et al. A randomized trial comparing the rate of hypoglycemia -- assessed using continuous glucose monitoring -- in 125 preschool children with type 1 diabetes treated with insulin glargine or NPH insulin (the PRESCHOOL study). Pediatr Diabetes. 2013;14(8):593-601. http://dx.doi.org/10.1111/pedi.12051

4. Murphy NP, Keane SM, Ong KK, et al. Randomized cross-over trial of insulin glargine plus lispro or NPH insulin plus regular human insulin in adolescents with type 1 diabetes on intensive insulin regimens. Diabetes Care. 2003;26(3):799-804. https://dx.doi.org/10.2337/diacare.26.3.799

5. Schober E, Schoenle E, Van Dyk J, Wernicke-Panten K; Pediatric Study Group of Insulin Glargine. Comparative trial between insulin glargine and NPH insulin in children and adolescents with type 1 diabetes. Diabetes Care. 2001;24(11):2005-2006. https://doi.org/10.2337/diacare.24.11.2005

6. Danne T, Becker RH, Ping L, Philotheou A. Insulin glargine metabolite 21^A-Gly-human insulin (M1) is the principal component circulating in the plasma of young children with type 1 diabetes: results from the PRESCHOOL study. Pediatr Diabetes. 2015;16(4):299-304. http://dx.doi.org/10.1111/pedi.12161

7. Bolli GB, Hahn AD, Schmidt R, et al. Plasma exposure to insulin glargine and its metabolites M1 and M2 after subcutaneous injection of therapeutic and supratherapeutic doses of glargine in subjects with type 1 diabetes. Diabetes Care. 2012;35(12):2626-2630. http://dx.doi.org/10.2337/dc12-0270

Glossary

Abasaglar = Abasaglar® (insulin glargine) 100 units/mL

IG-100 = insulin glargine 100 units/mL

Lantus = Lantus® (insulin glargine) 100 units/mL

M1 = 21A-Gly-human insulin

M2 = 21A-Gly-des-30B-Thr-human insulin

PK = pharmacokinetic

T1DM = type 1 diabetes mellitus