Zusammenfassung
Hintergrund
Insulin ist bei Kindern, die Typ-1-Diabetes entwickeln, meist das erste Ziel der Autoimmunreaktion und gilt deshalb als aussichtsreicher Kandidat für eine antigenspezifische Immunmodulation zur präventiven Behandlung der Erkrankung.
Studienresultate
Weltweit wurden in klinischen Studien schon mehrere hundert Kinder mit oralem Insulin in verschiedenen Dosierungen behandelt, ohne dass Nebenwirkungen auftraten. In 2 großen Studien konnte insgesamt kein präventiver Effekt mit täglich 7,5 mg Insulin oral bei betazellautoantikörperpositiven Personen erzielt werden, obgleich eine verzögerte Diabetesentwicklung in Subgruppen beobachtet wurde. In einer Pilotstudie jedoch wurde mit täglich 67,5 mg Insulin oral eine regulatorische Immunantwort gegen Insulin induziert.
Laufende Studien mit hochdosiertem oralem Insulin
Der präventive Effekt von täglich 67,5 mg Insulin oral auf die Diabetesentwicklung wird gegenwärtig geprüft; bei betazellautoantikörperpositiven Kindern mit einem asymptomatischen Frühstadium des Typ-1-Diabetes (Fr1da-Insulin-Interventions-Studie) sowie bei autoantikörpernegativen Kindern mit genetischem Risiko für Typ-1-Diabetes (POInT [„primary oral insulin trial“]).
Abstract
Background
Insulin is usually the first target of the autoimmune response in children developing type 1 diabetes and is therefore considered a promising candidate for an antigen-specific immunomodulation for the preventive treatment of the disease.
Study results
To date, several hundred of children worldwide have been treated with oral insulin in clinical studies, in various doses and without adverse reactions. Two large studies could not achieve a preventive effect with 7.5 mg oral insulin daily in β‑cell autoantibody-positive individuals overall, although delayed diabetes development was observed in subgroups. In a pilot study, 67.5 mg oral insulin daily induced a regulatory immune response against insulin.
Ongoing studies with high-dose oral insulin
The preventive effect of 67.5 mg oral insulin daily on diabetes development is currently under investigation: in β‑cell-autoantibody-positive children with an asymptomatic early stage of type 1 diabetes (Fr1da-Insulin-Intervention study) and in autoantibody-negative children with genetic risk for type 1 diabetes (POInT study [POInT: Primary Oral Insulin Trial]).
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Achenbach, P. Typ-1-Diabetes im asymptomatischen Frühstadium. Diabetologe 14, 234–239 (2018). https://doi.org/10.1007/s11428-018-0341-z
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DOI: https://doi.org/10.1007/s11428-018-0341-z