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Safety results from OCAPI: a European Observational Cohort Study of insulin glulisine-treated children aged 6-12

M Konstantinova1, V Loizeau2, V Pilorget3

  • 1University Paediatric Hospital, Sofia, Bulgaria.

Experimental and Clinical Endocrinology & Diabetes : Official Journal, German Society of Endocrinology [And] German Diabetes Association
|July 24, 2014
PubMed

Insights

Insulin glulisine is safe for children aged 6-12 with type 1 diabetes. The study found low rates of severe hypoglycemia and few adverse events, supporting its use in pediatric populations.

Area of Science:

  • Pediatric Endocrinology
  • Pharmacovigilance
  • Diabetes Mellitus Management

Background:

  • Limited safety data exists for insulin glulisine in pediatric type 1 diabetes patients.
  • The Observational prospective Cohort study of children with type 1 diabetes treated with APIDRA(®) (OCAPI) was designed to address this gap.
  • Focus was placed on evaluating safety in younger children (6-8 years).

Purpose of the Study:

  • To evaluate the real-world safety of insulin glulisine in children aged 6-12 years with type 1 diabetes.
  • To determine the incidence of severe hypoglycemia in this pediatric population.
  • To assess adverse reactions associated with insulin glulisine use.

Main Methods:

  • An international, multicenter, observational, non-interventional, prospective cohort study.
  • 94 children with type 1 diabetes (31 aged 6-8 years, 63 aged 9-12 years) received insulin glulisine for 6 months.
  • Primary endpoint was the incidence of severe hypoglycemia.

Main Results:

  • Overall severe hypoglycemia incidence was 6.6 events per 100 person-years.
  • Injection-site reactions occurred in 12 participants (9-12 years age group); no systematic hypersensitivity.
  • One serious event (severe hypoglycemia requiring ED visit) possibly related to insulin glulisine.

Conclusions:

  • Insulin glulisine demonstrates a favorable safety profile in children aged 6-12 years with type 1 diabetes.
  • Low rates of severe hypoglycemia and adverse events were observed.
  • Findings support the use of insulin glulisine in pediatric populations.
Abstract

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