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Treatment with insulin detemir or NPH insulin in children aged 2–5 yr with type 1 diabetes mellitus
Author(s) -
Thalange Nandu,
Bereket Abdullah,
Larsen Jens,
Hiort Line Conradsen,
Peterkova Valentina
Publication year - 2011
Publication title -
pediatric diabetes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.678
H-Index - 75
eISSN - 1399-5448
pISSN - 1399-543X
DOI - 10.1111/j.1399-5448.2010.00750.x
Subject(s) - medicine , insulin detemir , nph insulin , diabetes mellitus , type 2 diabetes mellitus , endocrinology , type 2 diabetes , adverse effect , insulin , pediatrics , gastroenterology , hypoglycemia , insulin glargine
Thalange N, Bereket A, Larsen J, Hiort LC, Peterkova V. Treatment with insulin detemir or NPH insulin in children aged 2–5 yr with type 1 diabetes mellitus. This randomised (1:1), multinational, open‐labelled, parallel group trial compared insulin detemir (IDet) with neutral protamine Hagedorn (NPH) insulin, in combination with mealtime insulin aspart, over 1 yr in subjects aged 2–16 yr with type 1 diabetes mellitus. Of 348 randomised subjects, 82 (23.6%) were 2–5 yr (IDet: 42, NPH: 40). This article is a descriptive subgroup analysis of these young children. Baseline characteristics (IDet vs. NPH) were similar: mean age, 4.3 vs. 4.5 yr; diabetes duration, 2.2 vs. 2.1 yr; males, 42.9 vs. 52.5%. Mean haemoglobin A1c (HbA1c) was similar between groups at baseline (8.2 vs. 8.1%), and changed little over 1 yr (8.1 vs. 8.3%). Fasting plasma glucose (FPG) was similar at baseline (8.44 vs. 8.56 mmol/L) and decreased during the study (−1.0 vs. −0.45 mmol/L). A lower rate of hypoglycaemia was observed with IDet compared with NPH (24‐h; 50.6 vs. 78.3 episodes per patient‐year; nocturnal hypoglycaemia, 8.0 vs. 17.4 episodes per patient‐year). No severe hypoglycaemic episodes occurred with IDet, while 3 subjects reported 6 episodes with NPH. Change in weight standard deviation score standardised by age and gender was −0.17 with IDet and +0.03 with NPH. A slightly lower proportion of subjects in this age group reported adverse events with IDet than with NPH (69.0 vs. 77.5%). Serious adverse events were few (5 with IDet, 7 with NPH). In conclusion, long‐term treatment with IDet in children aged 2–5 yr suggested similar glycaemic control, greater reduction in FPG, lower rates of hypoglycaemia, no inappropriate weight gain, and fewer adverse events compared with NPH.