Proleukin and Rapamune in Type 1 Diabetes

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Immune Tolerance Network (ITN)
• Treatments: Aldesleukin; Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.