The Diabetes Virus Detection and Intervention Trial
Condition: Type1 Diabetes Mellitus; Enterovirus
MeSH terms: Enterovirus Infections; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Ribavirin + Pleconaril; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Randomized to treatment with study drugs (ribavirin and pleconaril); Randomized to treatment with placebo
Intervention MeSH terms: Ribavirin; Pleconaril
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A double-blind, placebo controlled, prospective, randomized trial examining the effect of antiviral treatment given for 6months on residual insulin secretion
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 1 diabetes; Children; Enterovirus; Recent onset