Insulin detemir compared with NPH insulin in children and adolescents with Type 1 diabetes

Autor: Kenneth Robertson, Zoran Gucev, Johnny Ludvigsson, L. Mordhorst, M. A. Gall, E Schoenle
Rok vydání: 2007
Předmět:
Zdroj: Diabetic Medicine. 24:27-34
ISSN: 1464-5491
0742-3071
Popis: Aims This study compared the effect of insulin detemir on glycaemic control (HbA1c, fasting plasma glucose and variability thereof) with that of Neutral Protamine Hagedorn human isophane (NPH) insulin, both combined with insulin aspart, in children with Type 1 diabetes mellitus, and compared the safety of these treatments. Methods In this 26-week, open-label, randomized (2 : 1), parallel-group study, 347 (140 prepubertal and 207 pubertal) children with Type 1 diabetes, aged 6–17 years, received insulin detemir (n = 232) or NPH insulin (n = 115) once or twice daily, according to the prestudy regimen, plus premeal insulin aspart. Results The mean HbA1c decreased by ∼0.8% with both treatments. After 26 weeks, the mean difference in HbA1c was 0.1% (95% confidence interval −0.1, 0.3) (insulin detemir 8.0%, NPH insulin 7.9%). Within-subject variation in self-measured fasting plasma glucose was significantly lower with insulin detemir than with NPH insulin (SD 3.3 vs. 4.3, P
Databáze: OpenAIRE