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Insulin analogues in children with Type 1 diabetes: a 52-week randomized clinical trial

N Thalange1, A Bereket, J Larsen

  • 1Jenny Lind Children's Department, Norfolk and Norwich University Hospital, Norwich, UK. nandu.thalange@nnuh.nhs.uk

Diabetic Medicine : a Journal of the British Diabetic Association
|October 26, 2012
PubMed

Insights

Insulin detemir is as effective as NPH insulin for Type 1 diabetes in children and adolescents. This basal-bolus treatment showed fewer hypoglycaemic events and better weight management compared to NPH insulin.

Area of Science:

  • Pediatric Endocrinology
  • Metabolic Disorders
  • Diabetes Management

Background:

  • Type 1 diabetes mellitus (T1DM) requires lifelong management, often involving basal-bolus insulin regimens.
  • Optimizing glycemic control while minimizing adverse events like hypoglycemia and managing weight is crucial in pediatric T1DM patients.

Purpose of the Study:

  • To compare the efficacy and safety of insulin detemir versus neutral protamine Hagedorn (NPH) insulin in a basal-bolus regimen for children and adolescents with T1DM.
  • To assess glycemic control (HbA1c), hypoglycemia rates, and weight changes over a 52-week treatment period.

Main Methods:

  • A 52-week, randomized, multinational, open-label, parallel-group, non-inferiority trial.
  • 347 subjects aged 2-16 years with T1DM received either insulin detemir or NPH insulin, combined with insulin aspart.
  • Glycemic measurements and weight were monitored throughout the study.

Main Results:

  • Insulin detemir was non-inferior to NPH insulin regarding HbA1c levels after 52 weeks.
  • Significantly lower rates of 24-hour and nocturnal hypoglycemia were observed with insulin detemir.
  • Insulin detemir use was associated with a decrease in weight standard deviation (sd) scores, whereas NPH insulin showed a slight increase.

Conclusions:

  • Insulin detemir provides non-inferior glycemic control compared to NPH insulin in pediatric T1DM patients.
  • Insulin detemir offers a significant safety advantage with reduced hypoglycemia risk.
  • The study supports insulin detemir as a favorable option for weight management in this population.
Abstract

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