drugset / Trial / NCT02846545

A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes

NCT02846545 ↗

Phase 2 Completed 84 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary purpose of this study is to determine if golimumab can preserve beta-cell function in children and young adults with newly diagnosed Type 1 Diabetes (T1D).

Timeline

Start
2016-08-26
Primary completion
2019-05-21
Completion
2021-01-05

Outcome

Met primary endpoint

paper differed significantly between the golimumab group and the placebo group (0.64±0.42 pmol per milliliter vs. 0.43±0.39 pmol per milliliter, P<0.001). PMID 33207093 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Golimumab Monoclonal antibody — Subcutaneous