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Luis Sarmiento-Pérez

Assistant researcher

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An Exploratory Study of Itolizumab on the Preservation of Beta Cell Function in Adults with Recent-Onset Type 1 Diabetes

Author

  • Eduardo Cabrera-Rode
  • Ileana Cubas-Dueñas
  • Janet Rodríguez-Acosta
  • Yudith García-García
  • Yelena Torres-López
  • Claudia Prieto-Noa
  • Bárbara M. Vázquez-Izada
  • Maité Ruíz-Reinoso
  • Ragmila Echevarría-Valdés
  • Aimee Álvarez-álvarez
  • Emma Domínguez-Alonso
  • Ana Ibis Conesa-González
  • Teresa González-Calero
  • Erick Robles-Torres
  • Silvia Elena Turcios-Tristá
  • Elizabeth Senra-Estévez
  • Patricia Hernández-Casaña
  • Luis Sarmiento

Summary, in English

We conducted a phase I-IIa, randomized, monocentric, double-blind, placebo-controlled clinical trial to evaluate the safety and impact of the combination treatment of Itolizumab and insulin on preserving beta cell function in adults with recent-onset type 1 diabetes. Twelve patients were randomly assigned to three treatment groups, each receiving a different Itolizumab dose (0.4/0.8/1.6 mg/kg body weight, respectively) and a placebo group. All patients received concomitant intensive multiple-dose insulin therapy. Endogenous insulin secretion was assessed by the measurement of C-peptide during the mixed-meal tolerance test. No serious adverse events were reported. No changes in the total daily insulin doses, glycated hemoglobin levels, and stimulated C-peptide were observed between the Itolizumab and placebo groups at 52 weeks. A significant decrease in stimulated C-peptide was observed during the follow-up period (p = 0.012). One subject treated with 1.6 mg of Itolizumab showed a marked increase in the levels of stimulated C-peptide three years after completion of the trial. Taken together, this is the first study to demonstrate that combination treatment with Itolizumab and insulin is safe in humans and does not affect the residual function of beta cells up to 52 weeks. The findings from our study show preliminary evidence that high doses of Itolizumab could potentially arrest the loss of beta cell function in the long term. Further studies with a longer follow-up and larger numbers of patients are envisaged to assess the effect with high dose Itolizumab.

Department/s

  • Diabetes - Immunovirology
  • EXODIAB: Excellence of Diabetes Research in Sweden

Publishing year

2022-04-01

Language

English

Publication/Series

Journal of Clinical Medicine

Volume

11

Issue

7

Document type

Journal article

Publisher

MDPI AG

Topic

  • Endocrinology and Diabetes

Keywords

  • C-peptide
  • Human trials
  • Insulin
  • Itolizumab
  • Type 1 diabetes

Status

Published

Research group

  • Diabetes - Immunovirology

ISBN/ISSN/Other

  • ISSN: 2077-0383