CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 84 enrolled
Drug / intervention
Golimumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02846545
NCT02846545Phase 2Completed
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SIMPONI® to Arrest β-cell Loss in Type 1 Diabetes

Janssen Research & Development, LLC·interventional·Posted Jul 27, 2016·Updated Feb 4, 2025

In Brief

A Phase 2 clinical trial evaluating Golimumab and Placebo for Diabetes Mellitus, Type 1. Completed, enrolled 84 participants across 33 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 27, 2016
Enrollment StartAug 26, 2016
Primary CompletionMay 21, 2019
Study CompletionJan 5, 2021
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.9 years ago

Interventions

Golimumabbiological

Participants will receive subcutaneous golimumab intermittently for 52 weeks in double-blind period, where doses will be based on weight and/or body surface area. Participants meeting response criteria at Week 52, may receive golimumab SC for 50 weeks (doses will be based on weight and/or body surface area) in an OL extension period.

Placebobiological

Matching Placebo to golimumab.