Pleconaril and ribavirin in new-onset type 1 diabetes: a phase 2 randomized trial
Primary result · Stimulated serum C-peptide AUCResult — go to the resultAverage marginal effect 0.057 95% CI 0.004–0.11Authors' conclusion
The results show that antiviral treatment may preserve residual insulin production in children and adolescent with new-onset T1D.
Study context
- Population
- Children and adolescents (aged 6–15 years) with new-onset T1D; treatment initiated less than 3 weeks after diagnosis
- Participants
- 96 children
- Comparison
- Pleconaril and ribavirin vs placebo for 6 months
- Pleconaril and ribavirinn = 47
- Placebon = 49reference
- Primary endpoint
- Mean stimulated C-peptide AUC (mixed linear model of longitudinal log-transformed serum C-peptide AUCs at baseline, 3 months, 6 months and 1 year)
- Follow-up
- 12 months after initiation of treatment
Methodological detailsphase 2, placebo-controlled, parallel group, double-blind
- Phase 2
- Placebo-controlled
- Parallel group
- Double-blind
Primary result
Stimulated serum C-peptide AUC · 12 months
Average marginal effect
0.057
95% CI 0.004–0.11
P = 0.037
As reported in the abstract
Safety
Tolerability
- The treatment was well tolerated
Original publication
Pleconaril and ribavirin in new-onset type 1 diabetes: a phase 2 randomized trial. Nat Med. Published 4 October 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →