At a glance
ClinicalIndex Comparison Record- ✓Age 8–30 years
- ✓Diabetes duration 4–12 months
- ✓Weight greater than 27.5 kg
- ✓Stimulated C-peptide ≥0.2 pmol/mL
- ✕History of asthma
- ✕History of hepatitis C
- ✕History of hepatitis B
- ✕History of HIV
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of hOKT3gamma1(Ala-Ala) Teplizumab for Treatment of Patients With Recent Onset Type 1 Diabetes
In Brief
A Phase 2 clinical trial evaluating mAb hOKT3gamma1(Ala-Ala), Teplizumab and Placebo Arm for Type 1 Diabetes Mellitus. Completed, enrolled 63 participants across 4 sites.
Detailed Summary
This is a randomized placebo controlled study to test whether a single 14 course of treatment with the anti-CD3 monoclonal antibody, hOKT3gamma1(Ala-Ala),Teplizumab will prevent the loss of insulin secretory capacity in individuals with Type 1 diabetes of 4 - 12 months duration since diagnosis.
Study Details
Timeline
Interventions
This is a randomized, two-arm, double blind placebo controlled phase II trial in which 60 participants with recent-onset T1DM are randomized at a 1:1 ratio to receive Teplizumab or placebo over a 14 day treatment period. The course of Teplizumab comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2.