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

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT00505375

Run by

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

People needed

112

Starts

2008-02-01

Expected to finish

2012-05-01

Last updated by the study team

2020-05-06

Who can join

Age: 6 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Childrens Hospital Los Angeles — Los Angeles, California, United States
• University of California - San Francisco — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• The Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• University of Miami — Miami, Florida, United States
• Joslin Diabetes Center — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Columbia University, Naomi Berrie Diabetes Center — New York, New York, United States
• University of Pittsburgh, Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Texas, Southwestern Medical School — Dallas, Texas, United States
• Benaroya Research Institute — Seattle, Washington, United States
• The Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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