Diabetes Virus Detection
and Intervention Trial (DiViDInt)
EudraCT Number: 2015-003350-41
Accumulating evidence suggest that viruses may be an important factor in the pathogenesis of type 1 diabetes. We recently demonstrated a lowgrade, persistent enterovirus infection in the pancreatic islets of Langerhans of live patients at the diagnosis of T1D, and that about one third of the islets still produced insulin. We now want to test whether antiviral treatment may stop the disease process and maintain residual insulin production. Patients 5-16 years of age participate in a randomized, double blinded, placebo controlled trial of antiviral treatment with the combination of oral Pleconaril and Ribavirin. Study sites: Oslo and Copenhagen. All patients receive modern, intensified insulin treatment with insulin pumps or pens. Study drug treatment or placebo started within three weeks after diagnosis of T1D and last for 6 months. Follow-up at 3, 6, 12, 24, and 36 months. In October 2020 we included the last of the 96 patients according to protocol.
Endpoints: Change in mean residual insulin secretion measured by stimulated C-peptide (MMTT) and number of patients with clinical significant C-peptide.
Fasting and meal stimulated C-peptide from blood sampled monthly at home. Insulin dosage. HbA1c. Hypoglycemic events. Proinsulin/c-peptide ratio in serum as a measure of beta cell stress. Change in presence of Enterovirus in nose, blood and stool.
If antiviral treatment is effective, it will add proof to the concept that type 1 diabetes in its origin may be a viral disease. This would be an important milestone in medical research and be a breakthrough to the understanding of the ethiopathogenesis of autoimmune diseases. It may promote the development of vaccines to prevent the disease.
News from 2022: Primary endpoint analysis completed, and publication in preparation.