Antibody Response to Insulin Aspart and Human Insulin in Children and Adolescents with Newly Diagnosed Type I Diabetes

Holmberg, Hanna; Mersebach, Henriette; Hanzel, Karin Kanc; Ludvigsson, Johnny
June 2007
Diabetes;Jun2007 Supplement 1, Vol. 56, pA476
Academic Journal
The aim of this study was to compare levels of insulin antibodies in children and adolescents following initiation of insulin therapy with either insulin aspart (IAsp) or human insulin (HI) both in combination with NPH insulin. The relationship between insulin antibodies and either HbA[sub 1c] or insulin dose were also tested. IAsp specific antibodies (IAsp-Ab) and antibodies cross-reacting with HI and IAsp (HI-cross-Ab) were analyzed by radioimmunoassay at diagnosis of diabetes and every 3-6 months for 30 months. Seventy-two newly diagnosed children and adolescents, aged 2-17 years treated with HI (n = 30) or IAsp (n = 42) both in combination with NPH insulin were included. Data on HbA[sub 1c], insulin dose and serious adverse events (SAEs) were collected retrospectively. The level of IAsp-Ab remained low throughout the study. After 9 months of treatment, the level of HI-cross-Ab increased from a low baseline level to a mean (SD) of 48.75% (21.53) and 40.20% (17.92) in the HI and IAsp group, respectively and remained elevated. In a repeated measurement analysis of HI-cross-Ab levels, no statistical significance was found between treatment groups (p=0.16), although HI-cross-Ab were significantly associated with total insulin dose (U/kg) at 18 months (p=0.001) and time (p<0.0001), but not with HbA1c at 18 months (p=0.24). The mean total daily insulin dose was within 0.7-1.0 U/kg in both groups throughout the study. Mean (SD) HbA[sub 1c] in the HI and IAsp groups were similar at diagnosis, 9.52% (1.97) and 9.57% (1.62), respectively; HbA[sub 1c] then decreased to 5.45% (1.40) and 4.81% (0.93) at 6 months. Thereafter HbA[sub 1c] stabilized about 6% in both groups for the remaining period. SAEs were reported by HI: n=5, 14 events and IAsp: n=3, 3 events, respectively; the majority of these being hypoglycemic episodes. In conclusion, both treatment with IAsp and with HI was associated with an increase in HI-cross-Ab in insulin naive children, but with no measurable influence on treatment efficacy or safety. These results support the safe use of IAsp in children and adolescents with type 1 diabetes.


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