In the international Pre-POINT study, published in the renowned scientific journal JAMA, DZD scientists at the Paul Langerhans Institute Dresden and the Helmholtz Zentrum München achieved a breakthrough in the prevention of type 1 diabetes together with researchers from Vienna, Bristol and Denver (USA): They completed the first step in development of an insulin vaccine successfully.
The study, a double-blind, placebo-controlled, dose-escalation, assessed the immune responses and adverse events associated with orally administered insulin in autoantibody-negative, genetically at-risk children. The immune response to insulin was measured as serum IgG and saliva IgA binding to insulin, and CD4+ T-cell proliferative responses to insulin. In this pilot study of children at high risk for type 1 diabetes, daily oral administration of 67.5 mg of insulin, compared with placebo, resulted in an immune response without hypoglycemia. These findings support the need for a phase 3 trial to determine whether oral insulin can prevent islet autoimmunity and diabetes in such children.
Bonifacio E, Ziegler AG, Klingensmith G, Schober E, Bingley PJ, Rottenkolber M, Theil A, Eugster A, Puff R, Peplow C, Buettner F, Lange K, Hasford J, Achenbach P. Pre-POINT Study Group. Effects of High-Dose Oral Insulin on Immune Responses in Children at High Risk for Type 1 Diabetes: The Pre-POINT Randomized Clinical Trial. doi: 10.1001/jama.2015.2928, JAMA April 21, 2015
Link to the publication:http://jama.jamanetwork.com/article.aspx?articleid=2275446