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

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 1

Intervention: Alpha 1-Antitrypsin (AAT, Aralast NP) (Drug)

Phase: Phase 2

Status: Not yet recruiting

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

Summary

The drug Alpha-1 Antitrypsin (AAT, Aralast NP), which is being tested in this clinical trial,is an anti-inflammatory drug that affects the cells that are thought to be involved in the development of type 1 diabetes. This trial, known as RETAIN, is a two-part trial to investigate the effect of intravenous Alpha-1 Antitrypsin(AAT, Aralast NP) on preserving beta cell function and to determine if AAT will help slow the progression of type 1 diabetes.

Part I of this clinical trial is an open-label, safety and dose level study consisting of two groups. In Part I, all participants will receive the experimental drug and will be tested to see if the drug is safe and well tolerated. Two groups of participants with new-onset type 1 diabetes will be enrolled. After participants have completed the trial and a satisfactory safety review is completed, enrollment in Part II (NCT#) of the study will begin.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Mixed-Meal Tolerance Test (MMTT)-stimulated 2-hour C-peptide Area under the curve (AUC)

Secondary outcome:

MMTT-stimulated peak and 4-hour C-peptide AUC

MMTT-stimulated 2-hour C-peptide AUC assessed longitudinally

Insulin use in units per kilogram body weight per day

Hypoglycemic events occurring from randomization

Glycosylated hemoglobin (HbA1C) levels

Emergence of anti-AAT antibodies

Frequency and severity of all AEs (including infusion reactions, hypersensitivity reactions, and viral infections)

Changes in D-dimer levels indicating alteration in coagulant/anticoagulant balance

Pharmacokinetic parameters of Aralast NP

Detailed description: Type 1 diabetes mellitus 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 beta cells are destroyed by your immune cells, your ability to produce insulin is decreased. Insulin helps keep blood glucose levels normal.

People with type 1 diabetes 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 Antitrypsin (AAT, Aralast NP) has been shown to reverse new-onset diabetes and induce a state of self-tolerance. The RETAIN study is a two-part trial investigating the effect of intravenous Alpha-1 antitrypsin(AAT, Aralast NP) on preserving beta cell function and whether AAT will help slow the progression of type 1 diabetes.

Eligibility

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

Criteria:

Inclusion Criteria:

- Diagnosed with type 1 diabetes 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 > 0. 2 pmol/mL following a mixed meal tolerance test

(MMTT)

Exclusion Criteria:

- Serve 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 HBV, HCV, HIV or toxoplasmosis

- Clinically active infection with EBV, CMV, or tuberculosis

- 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 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.

- 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.

Locations and Contacts

University of California San Diego, La Jolla, California 92093, United States

Barbara Davis Center, Aurora, Colorado 80045, United States

Yale University, New Haven, Connecticut 06520, United States

Atlanta Diabetes Associates, Atlanta, Georgia 30309, United States

Emory University, Atlanta, Georgia 30322, United States

University of Iowa, Iowa City, Iowa 52242, United States

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

Calvert Memorial Hospital, Prince Frederick, Maryland 20678, United States

Joslin Diabetes Center, Boston, Massachusetts 02215, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

University of Massachusetts Medical School, Worchester, Massachusetts 01655, United States

Columbia University, New York, New York 100027, United States

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

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

Cetero Research San Antonio, San Antonio, Texas 78229, United States

Additional Information

Click here for more information on clinical trials for newly diagnosed type 1 diabetes

Click here for Immune Tolerance Network website

Click here for the National Institute of Allergy and Infectious Diseases website

Starting date: October 2010
Last updated: August 16, 2010

Page last updated: October 04, 2010

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