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A Research Trial of Aralast in New Onset Diabetes (RETAIN)

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 1

Intervention: Aralast NP 45 mg dose (Biological); Aralast NP 90 mg dose (Biological); Aralast NP 180 mg dose (Biological)

Phase: Phase 1

Status: Terminated

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Gordon Weir, MD, Study Chair, Affiliation: Joslin Diabetes Center


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.

Clinical Details

Official title: Effect of Intravenous Alpha-1 Antitrypsin on Preserving Beta-cell Function in New-onset Type 1 Diabetes Mellitus (ITN041AI)

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: C-peptide 2-hour AUC in Response to a Mixed-meal Tolerance Test at Week 52

Detailed description: Researchers are interested in conducting this study to assess whether Aralast NP (AAT, Alpha-1 Antitrypsin ) will help slow the progression of T1DM.

Part I of this study has two parts:-1a and - 1b:

Part 1a (Complete): An open-label, dose-escalation, PK, PD and safety study. Participants receive 12 intravenous (IV) infusions of Aralast NP. Infusions 1 through 6 are administered at 45 mg/kg/wk and infusions 7 through 12 are administered at 90 mg/kg/wk. Part Ia consists of two groups:

- Subjects aged 16 - 35 years at enrollment with new-onset T1DM

- Subjects aged 8 -15 years at enrollment with new-onset T1DM.

Part 1b (study terminated prior to subject enrollment): An open-label, dose-escalation PK, PD and safety study in which participants receive 12 infusions of Aralast NP. Infusions 1 through 6 are administered at 90 mg/kg/wk and infusions 7 through 12 are administered at 180 mg/kg/wk. Part Ib consists of two groups:

- Subjects aged 16 - 35 years at enrollment with new-onset T1DM

- Subjects 8 - 15 years at enrollment with new-onset T1DM.

Participants in Part Ib do not roll over into Part II (Refer to NCT01183455).


Minimum age: 8 Years. Maximum age: 35 Years. Gender(s): Both.


Inclusion Criteria:

- 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) Exclusion Criteria:

- 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


- 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.

Locations and Contacts

RADY Children's Hospital (University of California, San Diego), San Diego, California 92093, United States

Barbara Davis Center (University of Colorado), Aurora, Colorado 80045, United States

Yale University, New Haven, Connecticut 06520, United States

Atlanta Diabetes Associates, Atlanta, Georgia 30309, United States

Children's Hospital of Atlanta (Emory University), Atlanta, Georgia 30322, United States

University of Iowa Children's Hospital, Iowa City, Iowa 52242, United States

University of Maryland Medical Center, Baltimore, Maryland 21201, United States

Joslin Diabetes Center, Boston, Massachusetts 02215, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

University of Massachusetts Memorial Medical Center, Worchester, Massachusetts 01655, United States

Children's Mercy Hospital, Kansas City, Missouri 64108, United States

Naomi Berrie Diabetes Center (Columbia University), New York, New York 10032, United States

Nationwide Children's Hospital, Columbus, Ohio 43205, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States

Pacific Northwest Research Institute-University of Washington, Seattle, Washington 98122, United States

Additional Information

National Institute of Allergy and Infectious Diseases (NIAID) website

Immune Tolerance Network (ITN) website

Juvenile Diabetes Research Foundation (JDRF)

Starting date: October 2010
Last updated: January 14, 2015

Page last updated: August 23, 2015

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