Trial reportDiabetic medicine : a journal of the British Diabetic Association2013
Insulin analogues in children with Type 1 diabetes: a 52-week randomized clinical trial.
Trial report in Diabetic medicine : a journal of the British Diabetic Association, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00435019 (An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Efficacy and Safety Comparison of Insulin Detemir vs. NPH Insulin in Children and Adolescents Diagnosed With Type 1 Diabetes
Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 39 citations in OpenAlex.
- (Ultra-)long-acting insulin analogues for people with type 1 diabetes mellitus.The Cochrane database of systematic reviews · 2021Pooled it
- Long-acting insulin analogues for type 1 diabetes: An overview of systematic reviews and meta-analysis of randomized controlled trials.PloS one · 2018Pooled it
- Trial
- The efficacy of insulin degludec and insulin glargine over NPH insulin among toddlers and preschoolers with type 1 diabetes using glycemic variability and time in range.European journal of pediatrics · 2023Article
- 100 years on: the impact of the discovery of insulin on clinical outcomes.BMJ open diabetes research & care · 2021Review
- Comparison of Insulin Glargine and Detemir Effects on Hormones of Appetite and Metabolic Control in Patients with Type 1 Diabetes: A Randomized Clinical Trial.Iranian journal of pharmaceutical research : IJPR · 2021Article
- Reporting of hypoglycaemia in clinical trials of basal insulins: A need for consensus.Diabetes, obesity & metabolism · 2019Review
- Development of Insulin Detemir/Insulin Aspart Cross-Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2-16 Years.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2016Article
- Weight-sparing effect of insulin detemir: a consequence of central nervous system-mediated reduced energy intake?Diabetes, obesity & metabolism · 2015Review
- Effect of combined application insulin and insulin detemir on continous glucose monitor in children with type 1 diabetes mellitus.International journal of clinical and experimental medicine · 2015Article
- A multicenter observational safety study in Swedish children and adolescents using insulin detemir for the treatment of type 1 diabetes.Pediatric diabetes · 2013Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThis 52-week, randomized, multinational, open-label, parallel-group, non-inferiority trial investigated the efficacy and safety of basal-bolus treatment with insulin detemir vs. NPH (neutral protamine Hagedorn) insulin, in combination with insulin aspart, in subjects aged 2-16 years with Type 1 diabetes mellitus.
methodsOf the 347 randomized and exposed subjects, 177 received insulin detemir and 170 NPH insulin, both administered once or twice daily in combination with mealtime insulin aspart. Glycaemic measurements and weight were followed over 52 weeks.
resultsAfter 52 weeks, insulin detemir was shown to be non-inferior to NPH insulin with regard to HbA(1c) [mean difference insulin detemir-NPH: 1.30 mmol/mol, 95% CI -1.32 to 3.92 (0.12%, 95% CI -0.12 to 0.36) in the full analysis set and 1.41 mmol/mol, 95% CI -1.26 to 4.08 (0.13%, 95% CI -0.12 to 0.37) in the per protocol analysis set]. Hypoglycaemic events per subject-year of exposure of 24-h and nocturnal hypoglycaemia were significantly lower with insulin detemir than with NPH insulin (rate ratio 0.76, 95% CI 0.60-0.97, P = 0.028 and 0.62, 95% CI 0.47-0.84, P = 0.002, respectively). Weight standard deviation (sd) scores (body weight standardized by age and gender) decreased with insulin detemir, but increased slightly with NPH insulin (change: -0.12 vs. 0.04, P < 0.001). At end of the trial, median insulin doses were similar in both treatment groups.
conclusionsInsulin detemir was non-inferior to NPH insulin after 52 weeks' treatment of children and adolescents aged 2-16 years, and was associated with a significantly lower risk of hypoglycaemia, together with significantly lower weight sd score when compared with NPH insulin.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.