Phase 2
Completed N=112
Intravenous CTLA4-lg Treatment in Recent Onset Type 1 Diabetes Mellitus
Source: ClinicalTrials.gov NCT00505375 ↗Enrolled (actual)
112
Serious AEs
16.1%
Results posted
Aug 2016
Primary outcomePrimary: Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4 Hour Mixed Meal Tolerance Test at the 2 Year Visit — 0.375; 0.266 nmol/L — p=0.0014
Summary
The purpose of this study is to determine whether treatment with CTLA4-Ig (Abatacept) in individuals with new onset T1DM will improve insulin secretion (C-peptide production) compared to placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4 Hour Mixed Meal Tolerance Test at the 2 Year Visit |
0.375; 0.266 | 0.0014 sig |
Eligibility Criteria
Inclusion Criteria
- Age 6-45
- Within 3 months (100 days) of diagnosis of T1DM based on ADA criteria
- At least one diabetes-related autoantibody
- Stimulated C-peptide level >0.2 pmol/ml by MMTT conducted 21 days after diagnosis of T1DM and within 37 days of randomization
- At least three months from last live immunization received and willing to forgo live vaccinations for three months following last dose of study treatment
Exclusion Criteria
- Immunodeficiency, chronic lymphopenia, active infection, positive PPD result or a history of malignancy
- Serologic evidence of current or past HIV, Hepatitis B or C
- Pregnancy, lactation, or intention of pregnancy while on study
- Current use of immunosuppressive agents, or medications known to influence glucose tolerance or glycemic control
- Current participation in another T1DM treatment study
Data sourced from ClinicalTrials.gov (NCT00505375). 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.