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

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborators: American Diabetes Association; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Juvenile Diabetes Research Foundation; National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Abatacept

Criteria

Inclusion Criteria:

1. Age 6-45

2. Within 3 months (100 days) of diagnosis of T1DM based on ADA criteria

3. At least one diabetes-related autoantibody

4. Stimulated C-peptide level >0.2 pmol/ml by MMTT conducted 21 days after diagnosis of T1DM and within 37 days of randomization

5. 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:

1. Immunodeficiency, chronic lymphopenia, active infection, positive PPD result or a history of malignancy

2. Serologic evidence of current or past HIV, Hepatitis B or C

3. Pregnancy, lactation, or intention of pregnancy while on study

4. Current use of immunosuppressive agents, or medications known to influence glucose tolerance or glycemic control

5. Current participation in another T1DM treatment study