A 26-week, randomized trial of insulin detemir versus NPH insulin in children and adolescents with type 2 diabetes (iDEAt2)

Mark D Wheeler, Margarita Barrientos-Perez, Fu Sung Lo, Bo Liang, Alison Lunsford, Ólöf Thórisdóttir, Nehama Zuckerman-Levin

Research output: Contribution to journalArticle

Abstract

There are limited studies evaluating the safety and efficacy of treatments in young people with type 2 diabetes (T2D). This study compared the efficacy and safety of insulin detemir versus neutral protamine Hagedorn (NPH) insulin, both in combination with metformin and lifestyle intervention, in children and adolescents with T2D. This randomized, open-label, phase 3 trial recruited patients (n = 42) aged 10–17 years diagnosed with T2D already receiving metformin ± other oral antidiabetic drugs ± basal insulin. Patients were randomized (1:1) to receive either insulin detemir or NPH insulin, both with the maximum tolerated dose of metformin, and lifestyle intervention, over 26 weeks. Enrollment terminated prematurely after 17 months due to a very slow recruitment rate (12% of the target met). After 26 weeks, the observed mean HbA1c value had decreased by 0.61% points in the insulin detemir group vs. 0.84% points in the NPH insulin group. The rate of symptomatic blood glucose-confirmed hypoglycemic episodes was 0.4 episodes/patient-year of exposure (PYE) for insulin detemir vs. 1.1 episodes/PYE for NPH insulin. Conclusion: No safety issues were revealed with either basal insulin. Due to the low number of patients recruited, no efficacy conclusions could be drawn. ClinicalTrials.govidentifier: NCT02131272.What is known:• There is a growing worldwide epidemic of type 2 diabetes in children and adolescents.• There is a lack of research and limited treatment options currently available in this population.What is new:• No safety issues with insulin detemir or neutral protamine Hagedorn insulin in children and adolescents with type 2 diabetes were observed.• Improving clinical trial recruitment, along with providing early, efficacious, and safe treatment options, in this population is critical.

Original languageEnglish (US)
Pages (from-to)1497-1503
Number of pages7
JournalEuropean Journal of Pediatrics
Volume177
Issue number10
DOIs
StatePublished - Oct 1 2018

Keywords

  • Adolescents
  • Children
  • Insulin detemir
  • NPH insulin
  • Type 2 diabetes

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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