A Phase 2 interventional study of Ribavirin + Pleconaril and Placebos in Type1 Diabetes Mellitus and Enterovirus, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 6 Years to 15 Years. Per ClinicalTrials.gov, last updated 2021-04-08.
Sponsored by Oslo University Hospital · Phase 2, Interventional, and Treatment
A randomized, double-blind, placebo-controlled study in 96 children and adolescents age 6-15 newly diagnosed with type 1 diabetes to describe the influence of antiviral treatment (Pleconaril and Ribavirin) on progression of disease and residual insulin secretion.
If antiviral treatment is efficient in halting the disease progression, it will be to great benefit for the participating patients. Maintenance or even an increase in beta cell mass due to regeneration will lead to improved endogenous insulin production and give a milder course of the disease with improved glycemic control. This will in a substantial way improve the long-term prognosis with less severe long term vascular complications.Some patients may have close to complete remission and be able to stop insulin treatment. If antiviral treatment is effective, it would add proof to the concept that type 1 diabetes in its origin is a viral disease. This would be an important milestone in medical research and a breakthrough in the understanding of the etiopathogenesis of autoimmune diseases. It may promote the development of vaccines to prevent the disease. T1D seems more aggressive in children than in adults, and the beta cell function decline rapidly compared to adults. As a consequence, the effect of antiviral treatment will potentially be more significant in children than in adults. Children have higher HbA1c which increases the risk of complications. Thus, T1D is a more aggressive disease in children than in adults and hence it's important to do this study in children. Pharmaceuticals are usually studied in different age intervals, commonly 1-6 years, 6-12 years and 12-15 years. For safety reasons and simplicity, the investigators want to start with the two older groups. The investigators will treat the participants with two antiviral medications (Pleconaril and ribavirin) or placebo in a double blind, randomized, placebo controlled, parallel group study. Pleconaril has previously been given in doses of 5-10mg/kg x 2-3 in clinical trials in children, thus achieving serum levels high enough for killing the majority of the viruses. The investigators have, due to the long treatment period, reduced the doses to 5 mg/kg x 2. Ribavirin will be given in dosages according to Summariy of product characteristics (SmPC). The investigators have chosen to administer Investigational Medicinal Product (IMPs) as an oral solution as this will make it easier to give the medication according to weight.
47 studies on the registry are indexed under Enterovirus Infections; 5 are open to participants now.
This study's enrollment of 96 is below the median of 150 across 31 interventional studies indexed under Enterovirus Infections.
Browse Enterovirus Infections studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pleconaril: 5 mg/kg x2 times a day for 26 weeks up to 40 kg. Max dose 300mg x2. Ribavirin:15 (7.5) mg/kg/day divided in two doses daily for 26 weeks: Max dose 1000mg/24h if body weight\<75kg and 1200mg if body weight\>75kg.
Drug: Ribavirin + Pleconaril
Receives placebo, on a double blind basis
Drug: Placebos
Randomized to treatment with study drugs (ribavirin and pleconaril)
Randomized to treatment with placebo
Insulin secretion
Change in mean residual insulin secretion in the Insulin tolerance test (ITT)-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to12 months after initiation of study treatment.
Time frame: 12 months
Insulin secretion
Change in mean residual insulin secretion in the ITT-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to 3 months after initiation of study treatment.
Time frame: 3 months
Insulin secretion
Change in mean residual insulin secretion in the ITT-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to 6 months after initiation of study treatment.
Time frame: 6 months
Insulin secretion
Change in mean residual insulin secretion in the ITT-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to 24 months after initiation of study treatment.
Time frame: 24 months
Insulin secretion
Change in mean residual insulin secretion in the ITT-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to 36 months after initiation of study treatment.
Time frame: 36 months
Stimulated c-peptide
Proportion of patients with peak residual insulin secretion measured by MMTT: stimulated C-peptide \>0.2 pmol/L
Time frame: 36 months
C-peptide filter paper
Fasting and meal stimulated C-peptide from blood sampled on filter paper at home at 4 weekly intervals throughout the study period
Time frame: 36 months
Insulin dose
Mean Insulin dosage per kilo bodyweight per 24 hours
Time frame: 36 months
HbA1c
HbA1c at every control
Time frame: 36 months
Hypoglycemic events
Number of severe hypoglycaemic events and less severe events requiring assistance from others with blood glucose values ≤ 3.9 mmol/L will be registered at each control
Time frame: 36 months
Insulin-dose-adjusted HbA1c (IDAA1c)
HbA1c adjusted to insulin dose
Time frame: 36 months
Proinsulin/c-peptide ratio in serum
Proinsulin/c-peptide ratio in serum as a measure of beta cell stress
Time frame: 36 months
Presence of enterovirus
Presence of enterovirus and rhinovirus and/or neutralizing antibodies against those viruses in nose, blood, saliva and stool
Time frame: 36 months
Plan to share: No — The data and material collected from the placebo-group will be shared with the "Innodia" consortium
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Oslo University Hospital