A Research Trial of Aralast in New Onset Diabetes (RETAIN)
Stopped early · Phase 1
Conditions studied: Diabetes Mellitus, Type 1
In brief
The drug Alpha-1 Antitrypsin (AAT, Aralast NP) is being tested in this study as an anti-inflammatory drug (a medication that decreases inflammation, which is part of the body's normal ability to fight infection and respond to injuries) that affects the cells thought to be involved in the development of type 1 diabetes mellitus (T1DM, T1D). All subjects enrolled in this study have new-onset T1DM (diagnosis of T1DM within 100 days of Visit 0; T1DM diagnosis fulfilling American Diabetes Association standard T1DM criteria). The focus of Part I of this trial (NCT01183468) is pharmacokinetics (PK), pharmacodynamics (PD) and safety. Upon completion of Part I, including a satisfactory safety review, enrollment in Part II (NCT01183455, Phase II Clinical Trial) will begin.
Key facts
- Study ID
- NCT01183468
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 17
- Starts
- 2010-10-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2018-06-13
Who can join
Age: 8 and older, up to 35. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed with T1DM within the past 100 days (of enrollment)
- 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 > 0.2 pmol/mL following a mixed meal tolerance test (MMTT)
You may not qualify if…
- Severe active disease (chronic active hepatitis; cardiac, pulmonary disease, hepatic, renal or immunodeficiency)
- History of any bleeding or clotting factor deficiencies, or stroke
- History of vascular disease or significant vascular abnormalities
- Positive serology of exposure to (hepatitis B virus) HBV, HCV (hepatitis C virus), HIV (human immunodeficiency virus) or toxoplasmosis
- Clinically active infection with EBV (Epstein-Barr virus), CMV (cytomegalovirus), 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 T1DM or immunologic status
- Prior treatment with Alpha 1-Antitrypsin (Aralast NP, AAT) or hypersensitivity to alpha 1-antitrypsin 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
- IgA (immunoglobulin A) 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
- RADY Children's Hospital (University of California, San Diego) — San Diego, California, United States
- Barbara Davis Center (University of Colorado) — Aurora, Colorado, United States
- Yale University — New Haven, Connecticut, United States
- Atlanta Diabetes Associates — Atlanta, Georgia, United States
- Children's Hospital of Atlanta (Emory University) — Atlanta, Georgia, United States
- University of Iowa Children's Hospital — Iowa City, Iowa, United States
- University of Maryland Medical Center — Baltimore, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Joslin Diabetes Center — Boston, Massachusetts, United States
- University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
- Children's Mercy Hospital — Kansas City, Missouri, United States
- Naomi Berrie Diabetes Center (Columbia University) — New York, New York, United States
- Nationwide Children's Hospital — Columbus, Ohio, United States
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Pacific Northwest Research Institute-University of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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