CompletedPhase 2

Intravenous CTLA4-lg Treatment in Recent Onset Type 1 Diabetes Mellitus

United States112 participantsStarted 2008-02

Plain-language 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.

Who can participate

Age range6 Years – 45 Years

SexALL

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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

What they're measuring

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

Timeframe: 2 years of follow up

Trial details

NCT IDNCT00505375

SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2012-05

Results submitted2016-05-12

View on ClinicalTrials.gov More Type 1 Diabetes Mellitus trials