A Research Trial of Aralast NP in New Onset Diabetes (RETAIN) - Part II
NCT ID: NCT01183455
Last Updated: 2014-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2010-10-31
2014-08-31
Brief Summary
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Part I of this trial (NCT 01183468) was an open-label, safety and dose level study consisting of two groups. After completion of Part I, including a satisfactory safety review, enrollment in Part II was to begin. Part II was designed as a two-arm, double-blind, placebo-controlled clinical trial, and participants were to be randomly assigned to either the Aralast NP treatment or placebo group.
Detailed Description
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Individuals with T1D who have the ability to produce some of their own insulin (even though they still need to take insulin) may be able to achieve better glucose control than people who produce no insulin at all. Better glucose control has been shown to reduce the long-term complications of diabetes. Previous research has shown that giving medicines to affect the immune system soon after type 1 diabetes is diagnosed may stop, delay or decrease the destruction of beta cells, resulting in better glucose control.
In mouse models of disease, alpha-1 proteinase inhibitors have been shown to reverse new-onset diabetes and induce a state of self-tolerance. The RETAIN clinical trial was intended to investigate the effect of Aralast NP on preserving beta cell function and slowing the progression of T1D.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Aralast NP
Participants will receive Aralast NP (90mg/kg) intravenously once a week for 12 weeks.
Aralast NP
Participants will receive IV infusions of Aralast NP (90mg/kg) once a week for 12 weeks.
Placebo
Participants will receive placebo intravenously once a week for 12 weeks.
Placebo
Participants will receive IV infusions of placebo once a week for 12 weeks.
Interventions
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Aralast NP
Participants will receive IV infusions of Aralast NP (90mg/kg) once a week for 12 weeks.
Placebo
Participants will receive IV infusions of placebo once a week for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
8 Years
35 Years
ALL
No
Sponsors
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Immune Tolerance Network (ITN)
NETWORK
Juvenile Diabetes Research Foundation
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Gordon Weir, MD
Role: STUDY_CHAIR
Joslin Diabetes Center
Locations
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University of California San Diego
La Jolla, California, United States
Barbara Davis Center
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
University of Iowa
Iowa City, Iowa, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Calvert Memorial Hospital
Prince Frederick, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
University of Massachusetts Medical School
Worchester, Massachusetts, United States
Columbia University
New York, New York, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
The Children's Hospital of Philadelphia
Philadephia, Pennsylvania, United States
Cetero Research San Antonio
San Antonio, Texas, United States
Countries
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Related Links
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National Institute of Allergy and Infectious Diseases (NIAID) website
Immune Tolerance Network website
Juvenile Diabetes Research Foundation (JDRF)
Other Identifiers
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DAIT ITN041AI Part II
Identifier Type: -
Identifier Source: org_study_id