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Insulin glargine in pediatric patients with type 1 diabetes in Japan

Tatsuhiko Urakami1, Yusuke Naito2, Yutaka Seino3

  • 1Department of Pediatrics, Nihon University School of Medicine, Tokyo, Japan.

Pediatrics International : Official Journal of the Japan Pediatric Society
|May 21, 2014
PubMed

Insights

Insulin glargine effectively improved glycemic control in Japanese children with type 1 diabetes, showing significant reductions in HbA1c and FPG. The treatment demonstrated good safety, with no significant impact on physical development.

Area of Science:

  • Pediatric Endocrinology
  • Metabolic Disorders
  • Pharmacovigilance

Background:

  • Post-marketing surveillance of insulin glargine in Japanese pediatric patients with type 1 diabetes.
  • Evaluation of real-world clinical safety and effectiveness data.

Purpose of the Study:

  • To assess the safety and efficacy of insulin glargine in Japanese pediatric patients with type 1 diabetes.
  • To analyze glycemic control (HbA1c, FPG) and adverse events.

Main Methods:

  • Prospective data collection over 24 weeks from 113 pediatric patients.
  • Analysis of baseline characteristics, HbA1c, FPG, medication, height, weight, and adverse events.
  • Safety and efficacy analyses performed on 73 and 70 patients, respectively.

Main Results:

  • Hypoglycemia occurred in 3 patients (2 severe), with full recovery.
  • Significant reduction in HbA1c (9.10% to 8.09%) and FPG across all patients.
  • Significant HbA1c decrease in both age groups (7-12 and 13-15 years); significant FPG decrease in the younger group.
  • No significant changes in BMI or obesity levels observed.

Conclusions:

  • Insulin glargine therapy provides good glycemic control (HbA1c, FPG) in Japanese pediatric type 1 diabetes patients.
  • The treatment is well-tolerated and safe in a clinical setting.
  • Insulin glargine showed minimal impact on the physical development of pediatric patients.
Abstract

Keywords:
degree of obesityglycemic controlhypoglycemiainsulin glarginepediatric patients with type 1 diabetes

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