Status:
WITHDRAWN
A Research Trial of Aralast NP in New Onset Diabetes (RETAIN) - Part II
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Immune Tolerance Network (ITN)
Juvenile Diabetes Research Foundation
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
8-35 years
Phase:
PHASE2
Brief Summary
Aralast NP (alpha-1 antitrypsin, AAT), an alpha-1 proteinase inhibitor (human), was the drug to be tested in this clinical trial. Aralast NP is an anti-inflammatory drug that affects the cells that ar...
Detailed Description
T1D is an autoimmune disease. This means that your immune system (the part of your body that helps fight infections) mistakenly attacks the cells that produce insulin (beta cells in the pancreas). As ...
Eligibility Criteria
Inclusion
- Diagnosed with type 1 diabetes (T1D) within the past 100 days
- Positive for at least one diabetes-related autoantibody (anti-GAD; anti-insulin, if obtained within 10 days of the onset of insulin therapy; IA-2 antibody and/or ICA, or ZnT8)
- Peak stimulated C-peptide level greater than (\>) 0.2 pmol/mL following a mixed meal tolerance test (MMTT)
Exclusion
- Severe active disease (hepatitis, cardiac or pulmonary disease, hypertension, immunodeficiency)
- History of any bleeding or clotting factor deficiencies, or stroke
- History of vascular disease or significant vascular abnormalities
- Positive serology exposure to hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or toxoplasmosis
- Clinically active infection with Epstein-Barr virus (EBV), cytomegalovirus (CMV), or tuberculosis (TB)
- Prior or current use of oral, inhaled or intranasal glucocorticoids, or any medication known to cause a significant, ongoing change in the course of T1D or immunologic status
- Prior treatment with alpha1-antitrypsin (AAT) or hypersensitivity to AAT or human plasma-derived products
- Current or prior (within the last 30 days) use of metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors or amylin
- Current use of any medication known to influence glucose tolerance (e.g., beta-blockers, angiotensin-converting enzyme inhibitors, interferons, quinidine anti-malarial drugs, lithium, niacin)
- Females who are pregnant or lactating, or are unwilling to defer pregnancy during study participation
- Immunoglobulin A (IgA) deficiency
- Uncontrolled hypertension
- Current life-threatening malignancy
- Any condition that in the investigator's opinion may compromise study participation or may confound the interpretation of the study results
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01183455
Start Date
October 1 2010
End Date
August 1 2014
Last Update
December 31 2014
Active Locations (15)
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1
University of California San Diego
La Jolla, California, United States, 92093
2
Barbara Davis Center
Aurora, Colorado, United States, 80045
3
Yale University
New Haven, Connecticut, United States, 06511
4
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30309