drugset / Trial / NCT05909800

Prolonged Remission Induced by Phenofibrate in Children Newly Diagnosed With Type 1 Diabetes.

NCT05909800

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this clinical trial is to evaluate of the effect of phenofibrate on the functions of beta cells in children with new diagnosis of type 1 diabetes. The main question it aims to answer is: whether phenofibrate may prolong residual beta-cell function therefore own insulin secretion. Participants will be asked to take a phenofibrate or identically appearing placebo (a neutral substance), orally, once daily, for 12 months with no knowledge what is administred to them. They will be invited for follow-up visits including blood tests every 3 months. Researchers will be monitoring the two groups for the safety of the phenofibrate, and at the trial end they compare the residual insulin secretion results in two groups.

Timeline

Start
2022-09-29
Primary completion
2024-07
Completion
2024-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Fenofibrate Small molecule 160 mg Oral