Abstract
Background and aim
Viral infections, inflammation, and beta-cell stress have been shown to contribute to the progression of type 1 diabetes (T1D). Treatments targeting each of these areas individually, when initiated shortly after diagnosis, have demonstrated improvements in insulin secretion (C-peptide levels).
Aim: To assess whether a 6-month combination therapy with antiviral agents (Ribavirin and Pleconaril), anti-inflammatory treatment (Etanercept), and beta-cell protective medication (Verapamil) can improve C-peptide levels in children newly diagnosed with T1D.
Rationale
A multi-component intervention could yield additive or synergistic benefits beyond those observed with monotherapy.
Material and methods
The IBR trial is a single-group, open-label, phase II pilot study. 24 patients aged 10–18 years with newly diagnosed T1D will be included and matched with controls from the INNODIA database.
Primary outcomes will be the change in mean residual insulin secretion (C-peptide levels), assessed by the area under the curve of a mixed-meal tolerance test, from visit 1 to 12 months after initiating study treatment.
Results
The application to CTIS has been submitted.
Conclusion and perspectives
This study explores a novel combination therapy for newly diagnosed T1D. If successful, it could decrease the need for exogenous insulin and reduce long-term complications. Findings may support larger-scale trials, potentially revolutionizing T1D treatment.
Viral infections, inflammation, and beta-cell stress have been shown to contribute to the progression of type 1 diabetes (T1D). Treatments targeting each of these areas individually, when initiated shortly after diagnosis, have demonstrated improvements in insulin secretion (C-peptide levels).
Aim: To assess whether a 6-month combination therapy with antiviral agents (Ribavirin and Pleconaril), anti-inflammatory treatment (Etanercept), and beta-cell protective medication (Verapamil) can improve C-peptide levels in children newly diagnosed with T1D.
Rationale
A multi-component intervention could yield additive or synergistic benefits beyond those observed with monotherapy.
Material and methods
The IBR trial is a single-group, open-label, phase II pilot study. 24 patients aged 10–18 years with newly diagnosed T1D will be included and matched with controls from the INNODIA database.
Primary outcomes will be the change in mean residual insulin secretion (C-peptide levels), assessed by the area under the curve of a mixed-meal tolerance test, from visit 1 to 12 months after initiating study treatment.
Results
The application to CTIS has been submitted.
Conclusion and perspectives
This study explores a novel combination therapy for newly diagnosed T1D. If successful, it could decrease the need for exogenous insulin and reduce long-term complications. Findings may support larger-scale trials, potentially revolutionizing T1D treatment.
| Originalsprog | Engelsk |
|---|---|
| Publikationsdato | 2025 |
| Status | Udgivet - 2025 |
| Begivenhed | DDEA Summer School on Diabetes, Metabolism & Classical Endocrinology for PhD Students - Sinatur Hotel Gl. Avernæs Helnæsvej 9, Ebberup, Danmark Varighed: 25 aug. 2025 → 28 aug. 2025 |
Konference
| Konference | DDEA Summer School on Diabetes, Metabolism & Classical Endocrinology for PhD Students |
|---|---|
| Lokation | Sinatur Hotel Gl. Avernæs Helnæsvej 9 |
| Land/Område | Danmark |
| By | Ebberup |
| Periode | 25/08/2025 → 28/08/2025 |