Trial design
T1D, Diabetes
DIABETES
We conducted this phase 2, randomized, placebo-controlled, double-blind, parallel-group clinical trial at two sites: Oslo University Hospital, Norway and Steno Diabetes Center Copenhagen/Herlev University Hospital, Copenhagen, Denmark. Participants were children and adolescents aged 6–15 years with newly diagnosed T1D, randomly assigned in a 1:1 ratio to receive either a combination of pleconaril and ribavirin or placebo. We used block randomization, stratified according to site. The trial included a screening period from the day of diagnosis until baseline (up to 3 weeks), a 26-week treatment period and a 26-week off-therapy follow-up period, as well as an ongoing extended follow-up of two additional years (to be reported). The trial was conducted in accordance with the principles of the Declaration of Helsinki 2013, the International Conference on Harmonization Good Clinical Practice guidelines and applicable regulatory requirements. Approvals were obtained from the governmental and regional research ethics committees in Oslo and Copenhagen. Written informed consent was obtained from the participant’s caregiver and participants gave their verbal consent after receiving age-adjusted information. For the complete study protocol, see the 