At a glance
ClinicalIndex Comparison Record- ✓Type 1 diabetes diagnosed within 8 weeks prior to study entry per ADA criteria
- ✓Body weight at least 25 kg (55 lbs)
- ✓Positive diabetes autoantibodies: insulin autoantibodies assessed within 10 days of insulin use, OR anti-GAD autoantibodies, OR anti-ICA512/IA-2 autoantibodies
- ✓Subject or guardian willing to provide informed consent
- ✕Prior participation in a clinical trial that could potentially affect diabetes condition or immunologic status
- ✕Participation in another investigational clinical trial within the 6 weeks prior to study entry
- ✕Pregnancy or breastfeeding
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Multiple-Dose Treatment of New Onset Type 1 Diabetes Mellitus With Anti-CD3 mAb
In Brief
A Phase 2 clinical trial evaluating Anti-CD3 mAb, Diabetes Standard of Care Treatment, and 1 other intervention for Diabetes Mellitus, Type 1. Completed, enrolled 83 participants across 7 sites.
Detailed Summary
Anti-CD3 monoclonal antibody (a.k.a. hOKT3gamma1 \[Ala-Ala\],teplizumab, MGA031) is a humanized antibody that is commonly used to prevent organ rejection. The purpose of this study is determine whether anti-CD3 mAb treatment can halt the progression of newly diagnosed type 1 diabetes.
Study Details
Timeline
Interventions
Daily 14-day dose escalation course at study entry, with possible second course after 12-month interval
Receipt of intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
Immediately following randomization, all participants regardless of arm allocation begin iron supplementation with either ferrous sulfate or multivitamin with iron.