Phase 2
N=112
Intravenous CTLA4-lg Treatment in Recent Onset Type 1 Diabetes Mellitus
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00505375 ↗Enrolled (actual)
112
Serious AEs
16.1%
Results posted
Aug 2016
Primary outcome: 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 nmol/L — p=0.0014
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CTLA-4 Ig (Drug); Placebo (Other)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Primary completion
- May 2012
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 |
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.
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.