Proleukin and Rapamune in Type 1 Diabetes
A Phase I Trial of Proleukin and Rapamune in Recent-onset Type 1 Diabetes Mellitus (ITN018AI)
1 other identifier
interventional
9
1 country
3
Brief Summary
This is a phase I trial in individuals who have been diagnosed with type 1 diabetes within the previous 3-48 months. The study is testing whether two immune system modifying drugs are safe when used in combination and if they have immune altering effects that indicate they can halt the progression of type 1 diabetes progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2007
Longer than P75 for phase_1
3 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
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 4, 2007
CompletedFirst Posted
Study publicly available on registry
September 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedFebruary 8, 2017
February 1, 2017
4.1 years
September 4, 2007
February 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and severity of adverse events and laboratory anomalies
through day 364
Secondary Outcomes (4)
AUC for C-peptide responses following MMTT
various
Frequency of severe hypoglycemia
various
Insulin dose in units per kilogram
various
HbA1c levels
various
Study Arms (1)
Rapamycin/IL-2 combination therapy
EXPERIMENTALIL-2 (Proleukin) was administered at 4.5 3 106 IU s.c., three times per week for 4 weeks for a total of 12 doses. Rapamycin (Rapamune or Sirolimus) was administered without a loading dose at 2 mg/day, with adjustments to maintain trough blood levels of 5-10 ng/mL for 3 months.
Interventions
Administered by subcutaneous injection at a dose of 4.5x10\^6 IU/day, three times weekly for 28 days starting on day 0.
Administered orally, initial daily dose of 2mg. At day 7, dose adjusted to achieve and maintain whole blood trough levels of 5-10 ng/ml.
Eligibility Criteria
You may qualify if:
- Diagnosed with type 1 diabetes (per ADA criteria) more than 3 but less than 48 months prior to enrollment;
- to 45 years of age;and
- Positive for at least one islet cell autoantibody (GAD65-antibody, CA512-antibody and/or ICA).
You may not qualify if:
- Chronic use of glucocorticoids or other immunosuppressive ages 4 weeks before enrollment;
- History of recurrent infections, other autoimmune diseases, cardiac disease, cataracts or other chronic medical conditions that investigators believe could compromise participant safety;
- Females who are pregnant, lactating intend to get pregnant, or are unwilling to undergo pregnancy testing during the study;
- Males who intend to father a pregnancy during the first 6 months of the study; or
- Participation in another clinical study within the last 30 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Naomi Berrie Diabetes Center, Columbia University
New York, New York, 10032, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Benaroya Research Institute
Seattle, Washington, 98101, United States
Related Publications (2)
Long SA, Rieck M, Sanda S, Bollyky JB, Samuels PL, Goland R, Ahmann A, Rabinovitch A, Aggarwal S, Phippard D, Turka LA, Ehlers MR, Bianchine PJ, Boyle KD, Adah SA, Bluestone JA, Buckner JH, Greenbaum CJ; Diabetes TrialNet and the Immune Tolerance Network. Rapamycin/IL-2 combination therapy in patients with type 1 diabetes augments Tregs yet transiently impairs beta-cell function. Diabetes. 2012 Sep;61(9):2340-8. doi: 10.2337/db12-0049. Epub 2012 Jun 20.
PMID: 22721971RESULTPrevel N, Allenbach Y, Klatzmann D, Salomon B, Benveniste O. Beneficial role of rapamycin in experimental autoimmune myositis. PLoS One. 2013 Nov 12;8(11):e74450. doi: 10.1371/journal.pone.0074450. eCollection 2013.
PMID: 24265670DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carla Greenbaum, MD
Benaroya Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2007
First Posted
September 6, 2007
Study Start
August 1, 2007
Primary Completion
September 1, 2011
Study Completion
September 1, 2013
Last Updated
February 8, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will share
Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.