Real-world efficacy and safety of insulin degludec with mealtime rapid-acting insulin in type 1 diabetes in Indian pediatric population

Abstract

Background: Insulin Degludec (IDeg) is a new ultra-long-acting basal insulin that has not been yet evaluated in Indian pediatric population. We aim to evaluate the efficacy and safety of IDeg as basal-bolus therapy in Indian pediatric patients affected by type 1 diabetes mellitus (T1DM).; Methods: A total of 30 pediatric and adolescent patients (17 boys, 13 girls; 22 were pre-pubertal) with T1DM who were on IDeg once daily participated in the study. All the patients received IDeg for at least 26 weeks along with rapid-acting mealtime insulin and their pre- and post-baseline characteristics (anthropometric data (BMI), age, duration of diabetes), metabolic (HbA1C), insulin requirement (unit/kg body weight per day) and number of hypoglycemia episodes were recorded along with the daily self-monitoring of blood glucose.; Results: There was a significant decline in HbA1c, FPG and bolus insulin dose from baseline to 26 weeks in the overall population (HbA1c: 9.65 ± 1.998% to 8.60 ± 1.631%, P  = 0.0014; FPG: 156.93 ± 42.373 mg/dL to 109.37 ± 28.531 mg/dL, P  = 0.000004; bolus insulin dose: 0.49 ± 0.208 U/kg/day to 0.35 ± 0.155 U/kg/day, P  = 0.00032). The basal insulin dose was significantly higher at 26 weeks compared to baseline dose (0.42 ± 0.134 U/kg/day to 0.46 ± 0.139 U/kg/day, P  = 0.04219). There was no significant change in BMI at 26 weeks.None of the patients experienced any DKA episode for 26 weeks. 16.7% patients had experienced at least one symptomatic hypoglycemia episode. On CGMS among the patients who were shifted from Glargine to degludec hypoglycemia were reduced significantly (overall hypoglycemia: 1.92 ± 1.26 to 0.35 ± 0.49 episodes over 3 days, P  = 0.0026 while nocturnal hypoglycemia: 0.92 ± 0.47 to 0.21 ± 0.42 episodes, P  = 0.0021). None of the patients had severe hypoglycemia episode.; Conclusion: In our study IDeg is found to be safe and effective long-acting basal insulin that can be used in Indian pediatric population with T1DM. However further long term prospective studies are required to evaluate the long term effects.; Competing Interests: The study was initiated after taking an approval from institutional ethics committee (Apollo Hospital, Delhi) and was conducted in accordance with principals of the Declaration of Helsinki and ICH Good Clinical Practice. Informed written Consent was taken from Parents before enrolling the child in study. Clinical Study Reference Application Number: IAH/076/02-17 Name of Ethics Committee: Institutional Ethics Committee-Clinical Studies, Indraprastha Apollo Hospital, New Delhi, India Ethics Committee Registration Number : ECR/5/Inst/DI/2013 Date of Approval: 3rd March, 2017This article does not include any individual participant’s data in any form. Informed written consent was taken from Parents before enrolling the child in study.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.