Fast-acting insulin aspart in pediatric type 1 diabetes mellitus patients in a tertiary care center: Indian experience

Authors

  • Inderpal Singh Kochar Pediatric and Adolescent Endocrinology, Indraprastha Apollo Hospital, New Delhi, India
  • Rakhi Jain Pediatric and Adolescent Endocrinology, Department of Pediatrics, GSVM Medical College, Kanpur, Uttar Pradesh, India

DOI:

https://doi.org/10.18203/2349-3933.ijam20230289

Keywords:

Pediatric, Type 1 diabetes, T1DM, Insulin therapy, Aspart, Glycemic control

Abstract

Background: The objective of this retrospective study was to evaluate the effectiveness and safety of fast-acting insulin aspart with additional drug excipients (L-arginine and niacinamide) in the Indian pediatric population.

Methods: Data of pediatric type 1 diabetes mellitus (T1DM) outpatients in the age group of 1 to 18 years on treatment with injection degludec as long-acting Insulin OD and faster aspart as rapid-acting mealtime insulin 5-minutes before the meal for 20-weeks, was collected from the medical records of subjects. The primary endpoint was the mean change in glycated hemoglobin (HbA1c) and the secondary endpoints were mean changes in fasting plasma glucose (FPG) and 1 and 2-hour postprandial glucose (PPG), from baseline to 20-weeks post-treatment. The safety of treatment was also evaluated.

Results: Data of 30 pediatric patients (Male: Female-14:16) with a mean age of 7.98 years was considered for this retrospective data analysis. Compared to baseline, there was a significant decline (p<0.001) in mean HbA1c levels by -0.72, in FPG by -32.87 mg/dl, in 1-hour PPG levels by -8.57 mg/dl, and 2-hour PPG levels by -11.3 mg/dl, after 20-weeks of treatment. Three and two patients reported symptomatic undocumented hypoglycemia and symptomatic documented hypoglycemia respectively, and one patient each reported local site reaction, and lipodystrophy. No episodes of nocturnal hypoglycemia were reported.

Conclusions: In Indian pediatric T1DM patients 20-weeks mealtime faster aspart along with insulin degludec provided effective glycemic control, and treatment resulted in lower HbA1c, FPG, and 1 and 2-hour PPG levels.

Conclusions: In Indian pediatric T1DM patients 20-weeks mealtime faster aspart along with insulin degludec provided effective glycemic control, and treatment resulted in lower HbA1c, FPG, and 1 and 2-hour PPG levels.

References

Simmons KM, Michels AW. Type 1 diabetes: a predictable disease. World J Diabetes. 2015;6:380-90.

Kumar KM. Incidence trends for childhood type 1 diabetes in India. Indian J Endocrinol Metab. 2015;19:S34-5.

International Diabetes Federation. IDF Diabetes Atlas, 9th edn. Brussels, Belgium: 2019. Available at: https://diabetesatlas.org/idfawp/resource-files/2019/07/IDF_diabetes_atlas_ninth_edition_en.pdf. Accessed on 23 October, 2022.

Eilander MM, De Wit M, Rotteveel J, Aanstoot HJ, Waarde WM, Houdijk EC et al. Diabetes IN develOpment (DINO): the bio-psychosocial, family functioning and parental well-being of youth with type 1 diabetes: a longitudinal cohort study design. BMC Pediatr. 2015;15:82

Kakleas K, Kandyla B, Karayianni C, Karavanaki K. Psychosocial problems in adolescents with type 1 diabetes mellitus. Diabetes Metab. 2009;35:339-50.

DiMeglio LA, Acerini CL, Codner E, Craig ME, Hofer SE, Pillay K et al. ISPAD Clinical Practice Consensus Guidelines 2018. Glycemic control targets and glucose monitoring for children, adolescents, and young adults with diabetes. Pediatr Diabetes. 2018;19(27):105-14.

Janež A, Guja C, Mitrakou A, Lalic N, Tankova T, Czupryniak L et al. Insulin Therapy in Adults with Type 1 Diabetes Mellitus: a Narrative Review. Diabetes Ther. 2020;11:387-409.

Joshi SR, Bhansali A, Bajaj S, Banzal SS, Dharmalingam M, Gupta S et al. Results from a dietary survey in an Indian T2DM population: a STARCH study. BMJ open. 2014;4:e005138.

Popkin BM, Horton S, Kim S, Mahal A, Shuigao J. Trends in diet, nutritional status, and diet-related noncommunicable diseases in China and India: the economic costs of the nutrition transition. Nutr Rev. 2001;59:379-90.

Mohan V, Shah SN, Joshi SR, Seshiah V, Sahay BK, Banerjee S et al. Current status of management, control, complications and psychosocial aspects of patients with diabetes in India: Results from the DiabCare India 2011 Study. Indian J Endocrinol Metabol. 2014;18:370.

Food and Drug Administration (FDA). Inactive ingredient search for approved drug products. Available at: https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm. Accessed on 23 October 2022.

Heise T, Pieber TR, Danne T, Erichsen L, Haahr H. A pooled analysis of clinical pharmacology trials investigating the pharmacokinetic and pharmacodynamic characteristics of fast-acting insulin aspart in adults with type 1 diabetes. Clin Pharmacokinet. 2017;56:551-9.

Evans M, Wilkinson M, Giannpolou A. Fast-Acting Insulin Aspart: The Rationale for a New Mealtime Insulin. Diabetes Ther. 2019;10:1793-800.

Buckley ST, Kildegaard J, Hoiberg-Nielsen R, Bekker Jeppesen C, Birk Olsen H, et al. Mechanistic Analysis into The Mode(S) Of Action of Niacinamide In Faster-Acting Insulin Aspart. Diabetes Technol Ther. 2016;A116:2525.

Bode BW, Iotova V, Kovarenko M, Laffel LM, Rao PV, Deenadayalan S et al. Efficacy and Safety of Fast-Acting Insulin Aspart Compared with Insulin Aspart, Both in Combination with Insulin Degludec, in Children and Adolescents with Type 1 Diabetes: The onset 7 Trial. Diabetes Care. 2019;42:1255-62.

Russell-Jones D, Bode BW, De Block C, Franek E, Heller SR, Mathieu C et al. Fast-Acting Insulin Aspart Improves Glycemic Control in Basal-Bolus Treatment for Type 1 Diabetes: Results of a 26-Week Multicenter, Active-Controlled, Treat-to-Target, Randomized, Parallel-Group Trial (onset 1). Diabetes Care. 2017;40:943-50.

Jones TW, Davis EA. Hypoglycemia in children with type 1 diabetes: current issues and controversies. Pediatr Diabetes. 2003;4:143-50.

De Block C, Carlson A, Rose L, Gondolf T, Gorst-Rasmussen A, Lane W. Hypoglycemia with Mealtime Fast-Acting Insulin Aspart vs. Insulin Aspart Across Two Large Type 1 Diabetes Trials. Diabetes. 2018;67(1):96-LB.

Evans M, Wilkinson M, Giannpolou A. Fast-Acting Insulin Aspart: The Rationale for a New Mealtime Insulin. Diabetes Ther. 2019;10:1793-800.

Senior P, Hramiak I. Fast-Acting Insulin Aspart and the Need for New Mealtime Insulin Analogues in Adults with Type 1 and Type 2 Diabetes: A Canadian Perspective. Can J Diabetes. 2019;43:515-23.

Downloads

Published

2023-02-03

Issue

Section

Original Research Articles