Pleconaril and ribavirin in new-onset type 1 diabetes: a phase 2 randomized trial
| العنوان: | Pleconaril and ribavirin in new-onset type 1 diabetes: a phase 2 randomized trial |
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| المؤلفون: | Krogvold, Lars, Mynarek, Ida Maria, Ponzi, Erica, Mork, Freja Barrett, Hessel, Trine Witzner, Roald, Trine, Lindblom, Nina, Westman, Jacob, Barker, Peter, Hyoety, Heikki, Ludvigsson, Johnny, Hanssen, Kristian F., Johannesen, Jesper, Dahl-Jorgensen, Knut |
| المصدر: | Nature Medicine. 29:2902-2908 |
| الوصف: | 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 beta 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. Results from the DiViD Intervention, a phase 2 randomized, placebo-controlled trial, showed that antiviral treatment with pleconaril and ribavirin for 6 months resulted in higher endogenous insulin production in children and adolescents with new-onset type 1 diabetes. |
| وصف الملف: | electronic |
| الوصول الحر: | https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-198659Test https://doi.org/10.1038/s41591-023-02576-1Test https://liu.diva-portal.org/smash/get/diva2:1806609/FULLTEXT01.pdfTest |
| قاعدة البيانات: | SwePub |
| تدمد: | 10788956 1546170X |
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| DOI: | 10.1038/s41591-023-02576-1 |