Immunogenicity of different brands of human insulin and rapid-acting insulin analogs in insulin-naïve children with type 1 diabetes.
OBJECTIVE
To determine (i) whether insulin preparations produced by three companies induce the same immune responses in insulin-naïve children with type 1 diabetes (T1DM); (ii) if switching from human insulin to rapid-acting insulin analogs influences this immune response; and (iii) if different insulin brands produce different clinical results during the first 2 yr after T1DM diagnosis.


METHODS
Insulin antibodies (IA) were measured for 140 patients aged 1.4-17.6 yr. Regular human insulin, neutral protamine Hagedorn (NPH) human insulin, and rapid-acting insulin analogs (lispro or aspart) taken by the patients were produced by one of three companies: Bioton, Poland (A), Eli Lilly, USA (B) and NovoNordisk, Denmark (C).


RESULTS
Positive IA levels were found in 112 patients (80.0%) at baseline and in 137 (97.9%) at 6 and at 24 months after T1DM diagnosis. There was no difference in IA levels among patients taking insulin preparations produced by different companies at 6 months (mean ± SD, A 27.8 ± 15.7%; B 25.3 ± 15.4%; C 24.5 ± 14.2; p = 0.54) or at 24 months (A 25.6 ± 17.8%; B29.6 ± 17.0%; C 26.2 ± 17.0%; p = 0.52); HbA(1c) and daily insulin dose did not differ significantly either. After 24 months, IA levels were similar for those who had used human insulin (mean ± SD, 25.7 ± 17.2%) and for those that had added rapid-acting analogs (28.1 ± 17.3%, p = 0.41).


CONCLUSIONS
Three brands of insulin preparations did not differ with respect to immunogenicity. Rapid-acting analogs did not increase IA levels in patients previously treated with human insulin only. Patients using insulin preparations of different brands did not differ with respect to daily insulin dose or HbA(1c) .
Mianowska
B
B
Department of Pediatrics, Oncology, Hematology and Diabetology, Medical University of Łódź, Łódź, Poland. cima@binar.pl
Szadkowska
A
A
Pietrzak
I
I
Zmysłowska
A
A
Wegner
O
O
Tomczonek
J
J
Bodalski
J
J
Młynarski
W
W
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000188:drug therapy* / Q000276:immunology; D004304:Dosage Forms; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007223:Infant; D007328:Insulin / Q000008:administration & dosage* / Q000031:analogs & derivatives* / Q000276:immunology*; D007330:Insulin Antibodies / Q000032:analysis* / Q000097:blood; D008297:Male
D004304:Dosage Forms; D006442:Glycated Hemoglobin; D007328:Insulin; D007330:Insulin Antibodies; C517652:hemoglobin A1c protein, human