A 26-week, randomized trial of insulin detemir versus NPH insulin in children and adolescents with type 2 diabetes (iDEAt2)
| Autor: | Ólöf Thórisdóttir, Mark D. Wheeler, Margarita Barrientos-Perez, Fu Sung Lo, Nehama Zuckerman-Levin, Alison Lunsford, Bo Liang |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Blood Glucose
Male medicine.medical_specialty endocrine system diseases Adolescent medicine.medical_treatment Insulin Isophane 030209 endocrinology & metabolism NPH insulin Hypoglycemic episodes Type 2 diabetes Adolescents law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Insulin Detemir law Internal medicine medicine Humans Hypoglycemic Agents 030212 general & internal medicine Child Children Life Style Insulin detemir Glycated Hemoglobin business.industry Insulin nutritional and metabolic diseases medicine.disease Metformin Diabetes Mellitus Type 2 Maximum tolerated dose Pediatrics Perinatology and Child Health Original Article Female business medicine.drug |
| Zdroj: | European Journal of Pediatrics |
| ISSN: | 1432-1076 0340-6199 |
| Popis: | 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.gov identifier: 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. Electronic supplementary material The online version of this article (10.1007/s00431-018-3205-z) contains supplementary material, which is available to authorized users. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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