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Antibody response to insulin in children and adolescents with newly diagnosed Type 1 diabetes
Author(s) -
Holmberg H.,
Mersebach H.,
Kanc K.,
Ludvigsson on behalf of the Insulin Aspart Study Group on Immunogenicity J.
Publication year - 2008
Publication title -
diabetic medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.474
H-Index - 145
eISSN - 1464-5491
pISSN - 0742-3071
DOI - 10.1111/j.1464-5491.2008.02468.x
Subject(s) - medicine , insulin , insulin aspart , diabetes mellitus , type 1 diabetes , endocrinology , regular insulin , adverse effect , type 2 diabetes , hypoglycemia
Aims To compare levels of insulin antibodies in children and adolescents after initiation of insulin therapy using either insulin aspart (IAsp) or human insulin (HI) in combination with Neutral Protamine Hagedorn (NPH) insulin, and to investigate the relationships between insulin antibodies and HbA 1c and insulin dose. Methods IAsp‐specific antibodies (IAsp‐Ab) and antibodies cross‐reacting with HI and IAsp (HI‐cross‐Ab) were analysed by radioimmunoassay at diagnosis of diabetes and every 3–6 months for 30 months. Seventy‐two patients (HI = 30, IAsp = 42) with Type 1 diabetes, aged 2–17 years were included. Data on HbA 1c , insulin dose and serious adverse events (SAEs) were collected retrospectively. Results IAsp‐Ab levels remained low throughout the study. After 9 months, the level of HI‐cross‐Ab increased [mean ( sd ) HI, 48.8% (21.53); IAsp, 40.2% (17.92)] and remained elevated. Repeated measurement analysis of HI‐cross‐Ab levels showed no significant difference between treatments ( P = 0.16). HI‐cross‐Ab were significantly associated with total insulin dose (U/kg) ( P = 0.001) and time ( P < 0.0001), but not with HbA 1c ( P = 0.24). Mean (± sd ) HbA 1c was similar at diagnosis (HI 9.5 ± 1.97%; IAsp 9.6 ± 1.62%); HbA 1c then decreased and stabilized to about 6.0% in both groups. Few SAEs were reported, the majority being hypoglycaemic episodes. Conclusions Treatment with IAsp and with HI was associated with an increase in HI‐cross‐Ab in insulin‐naive children, but this did not influence treatment efficacy or safety. These results support the safe use of IAsp in children and adolescents with Type 1 diabetes.