Study Stopped
Sponsor decision-lack of mechanistic signal and competing industry studies
A Research Trial of Aralast NP in New Onset Diabetes (RETAIN) - Part II
RETAIN
Effect of Intravenous Alpha-1 Antitrypsin on Preserving Beta-cell Function in New-onset Type 1 Diabetes Mellitus (ITN041AI)- Part II
1 other identifier
interventional
N/A
1 country
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2010
Typical duration for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2010
CompletedFirst Posted
Study publicly available on registry
August 17, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedDecember 31, 2014
December 1, 2014
3.8 years
August 16, 2010
December 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mixed-Meal Tolerance Test (MMTT)-Stimulated 2-hour C-peptide Area Under the Curve (AUC)
Week 52
Secondary Outcomes (9)
MMTT-Stimulated Peak and 4-hour C-peptide AUC
Weeks 52 and 104
MMTT-Stimulated 2-hour C-Peptide AUC Assessed Over Time
Weeks 0, 14, 26, 52, and 104
Insulin Use in Units Per Kilogram Body Weight Per Day
Weeks 52 and 104
Hypoglycemic Events Occurring from Randomization to End of Trial
Throughout the Study
Glycosylated Hemoglobin (HbA1c) Levels
Weeks 52 and 104
- +4 more secondary outcomes
Study Arms (2)
Aralast NP
EXPERIMENTALParticipants will receive Aralast NP (90mg/kg) intravenously once a week for 12 weeks.
Placebo
PLACEBO COMPARATORParticipants will receive placebo intravenously once a week for 12 weeks.
Interventions
Participants will receive IV infusions of Aralast NP (90mg/kg) once a week for 12 weeks.
Participants will receive IV infusions of placebo once a week for 12 weeks.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
University of California San Diego
La Jolla, California, 92093, United States
Barbara Davis Center
Aurora, Colorado, 80045, United States
Yale University
New Haven, Connecticut, 06511, 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
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
University of Massachusetts Medical School
Worchester, Massachusetts, 01655, United States
Columbia University
New York, New York, 10027, 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gordon Weir, MD
Joslin Diabetes Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2010
First Posted
August 17, 2010
Study Start
October 1, 2010
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
December 31, 2014
Record last verified: 2014-12