Phase III, randomised, double-blind, placebo-controlled, multicentre trial to evaluate the efficacy and safety of rhGAD65 to preserve endogenous beta cell function in adolescents and adults with recently diagnosed type 1 diabetes, carrying the genetic HLA DR3-DQ2 haplotype: the DIAGNODE-3 study protocol

Autor: Marcus Lind, Johnny Ludvigsson, Christoph Nowak, Linnea Eriksson, Pedro F Teixeira, Martina Widman, Anton Lindqvist, Rosaura Casas, Ulf Hannelius
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: BMJ Open, Vol 12, Iss 10 (2022)
Druh dokumentu: article
ISSN: 2044-6055
DOI: 10.1136/bmjopen-2022-061776
Popis: Introduction Type 1 diabetes (T1D) is an autoimmune disease leading to the destruction of the insulin-producing beta cells resulting in insulin deficiency and hyperglycaemic. Today, no approved therapy exists to halt this detrimental immunologic process. In a recent phase 2b study, intralymphatic administration of recombinant human glutamic acid decarboxylase 65 kDa (rhGAD65) adsorbed to Alhydrogel adjuvant to individuals recently diagnosed with T1D and carrying the HLA DR3-DQ2 haplotype showed promising results in preserving endogenous insulin secretion, confirming the results of a large meta-analysis of three randomised placebo-controlled trials of subcutaneous rhGAD65. The aim of the current precision medicine phase 3 study is to determine whether intralymphatic administration of rhGAD65 preserves insulin secretion and improves glycaemic control in presumed responder individuals with recently diagnosed T1D carrying HLA DR3-DQ2.Methods and analysis Individuals ≥12 and
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