At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 15 enrolled
Drug / intervention
Anakinradrug
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.
An Exploratory, Open Label Study of Anti-inflammatory Therapy With Anakinra in Children With Newly Diagnosed Type 1 Diabetes Mellitus
University of Texas Southwestern Medical Center·interventional·Posted Mar 28, 2008·Updated Nov 14, 2019
In Brief
A Phase 2 clinical trial evaluating Anakinra for Type 1 Diabetes Mellitus. Completed, enrolled 15 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether control of inflammatory pathways mediated by IL-1 beta using the IL-1 receptor antagonist anakinra will yield measurable decreases in expression of genes that are otherwise overexpressed as a consequence of IL-1 beta effects in children with newly diagnosed type 1 diabetes. Ultimately, we believe that control of IL-1 beta pathways will be associated with preserved insulin secretory capacity.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsChildren's Medical Center Dallas
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2008
First PostedMar 2008
Primary CompletionSep 2009
TodayJul 2026
First PostedMar 28, 2008
Enrollment StartMar 1, 2008
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.3 years ago
Interventions
Anakinradrug
Patients will receive daily anakinra therapy for 28 days