Phase 2
Completed N=63
Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes
Source: ClinicalTrials.gov NCT00378508 ↗Enrolled (actual)
63
Serious AEs
1.6%
Results posted
Oct 2012
Primary outcomePrimary: C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at 12 Months — 0.451; 0.371 pmol/ml
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at 12 Months |
0.451; 0.371 | — |
| PRIMARY C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) at Baseline |
0.593; 0.554 | — |
| SECONDARY Hemoglobin A1c |
6.85; 7.35 | — |
| SECONDARY Average Insulin Use Over 12 Months |
0.475; 0.574 | — |
| SECONDARY Baseline Insulin Use |
0.405; 0.386 | — |
| SECONDARY Baseline Hemoglobin A1c |
6.32; 7.1 | — |
Eligibility Criteria
Inclusion Criteria
- age 8 - 30,
- duration of diabetes 4 - 12 months,
- weight greater than 27.5 kg,
- stimulated C-peptide >= 0.2 pmol/ml
Exclusion Criteria
- asthma,
- history of hepatitis C, hepatitis B, HIV
Data sourced from ClinicalTrials.gov (NCT00378508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.