A Research Trial of Aralast NP in New Onset Diabetes (RETAIN) - Part II

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 1

In brief

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 are thought to be involved in the development of type 1 diabetes mellitus (T1DM, T1D). This study, known as RETAIN, was planned as a two-part trial to investigate the effect of Aralast NP on preserving beta cell function and to determine if the intervention would slow the progression of type 1 diabetes. 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.

Key facts

Study ID

NCT01183455

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

0

Starts

2010-10-01

Expected to finish

2014-08-01

Last updated by the study team

2014-12-31

Who can join

Age: 8 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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