Pleconaril and ribavirin in new-onset type 1 diabetes: a phase 2 randomized trial

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  • Lars Krogvold
  • Ida Maria Mynarek
  • Erica Ponzi
  • Freja Barrett Mørk
  • Trine Witzner Hessel
  • Trine Roald
  • Nina Lindblom
  • Jacob Westman
  • Peter Barker
  • Heikki Hyöty
  • Johnny Ludvigsson
  • Kristian F. Hanssen
  • Johannesen, Jesper
  • Knut Dahl-Jørgensen

Previous studies showed a low-grade enterovirus infection in the pancreatic islets of patients with newly diagnosed type 1 diabetes (T1D). In the Diabetes Virus Detection (DiViD) Intervention, a phase 2, placebo-controlled, randomized, parallel group, double-blind trial, 96 children and adolescents (aged 6–15 years) with new-onset T1D received antiviral treatment with pleconaril and ribavirin (n = 47) or placebo (n = 49) for 6 months, with the aim of preserving β cell function. The primary endpoint was the mean stimulated C-peptide area under the curve (AUC) 12 months after the initiation of treatment (less than 3 weeks after diagnosis) using a mixed linear model. The model used longitudinal log-transformed serum C-peptide AUCs at baseline, at 3 months, 6 months and 1 year. The primary endpoint was met with the serum C-peptide AUC being higher in the pleconaril and ribavirin treatment group compared to the placebo group at 12 months (average marginal effect = 0.057 in the linear mixed model; 95% confidence interval = 0.004–0.11, P = 0.037). The treatment was well tolerated. The results show that antiviral treatment may preserve residual insulin production in children and adolescent with new-onset T1D. This provides a rationale for further evaluating antiviral strategies in the prevention and treatment of T1D. European Union Drug Regulating Authorities Clinical Trials identifier: 2015-003350-41 .

Original languageEnglish
JournalNature Medicine
Issue number11
Pages (from-to)2902-2908
Number of pages7
Publication statusPublished - 2023

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