Proleukin and Rapamune in Type 1 Diabetes
Completed · Phase 1
Conditions studied: Diabetes Mellitus, Type 1
In brief
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.
Key facts
- Study ID
- NCT00525889
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 9
- Starts
- 2007-08-01
- Expected to finish
- 2013-09-01
- Last updated by the study team
- 2017-02-08
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed with type 1 diabetes (per ADA criteria) more than 3 but less than 48 months prior to enrollment;
- 18 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.
Where it is running
- Naomi Berrie Diabetes Center, Columbia University — New York, New York, United States
- Oregon Health Sciences University — Portland, Oregon, United States
- Benaroya Research Institute — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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