Phase 2
N=77
Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes
Diabetes Mellitus, Type 1
Bottom Line
View on ClinicalTrials.gov: NCT00129259 ↗Enrolled (actual)
77
Serious AEs
14.3%
Results posted
Sep 2013
Primary outcome: Primary: Change in Mean C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) — -0.28; -0.46 pmol/mL — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Anti-CD3 mAb (Biological); Diabetes Standard of Care Treatment (Other); Iron supplementation (Dietary_supplement)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) |
-0.28; -0.46 | 0.002 sig |
| SECONDARY Change in HbA1c |
0.129; 0.195 | 0.697 |
| SECONDARY Change in Average Total Insulin Dose Per Body Weight |
0.23; 0.35 | 0.110 |
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of type 1 diabetes (according to American Diabetes Association [ADA] criteria) within the 8 weeks prior to study entry
- Weigh at least 25 kg (55 lbs)
- Insulin autoantibodies assessed within 10 days of any insulin use OR anti-glutamic acid decarboxylase (GAD) autoantibodies OR anti-ICA512/IA-2 autoantibodies
- Subjects or guardian(s) willing to provide informed consent
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00129259). 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.