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Proleukin and Rapamune in Type 1 Diabetes

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 1

Intervention: IL-2 (Drug); sirolimus (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Carla Greenbaum, MD, Principal Investigator, Affiliation: Benaroya Research Institute


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.

Clinical Details

Official title: A Phase I Trial of Proleukin and Rapamune in Recent-onset Type 1 Diabetes Mellitus (ITN018AI)

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

Primary outcome: incidence and severity of adverse events and laboratory anomalies

Secondary outcome:

AUC for c-peptide responses following MMTT

frequency of severe hypoglycemia

insulin dose in units per kilogram

HbA1c levels

Detailed description: At the time of diagnosis with type 1 diabetes, 15-40% of beta cells may remain active and healthy in the pancreas, capable of producing insulin the body needs to regulate blood glucose levels. Because even small amounts of natural insulin production can decrease the long term effects of diabetes, it is essential that these cells are preserved. This trial will test whether a combination of the drugs Proleukin (IL-2) and Rapamune (sirolimus) may be safely administered to recently diagnosed type 1 diabetes patients and whether it causes changes to the immune system that can halt the autoimmune destruction of the remaining beta cells. This drug combination has been found to be effective for long-term diabetes prevention in mouse models of type 1 diabetes. This study is a phase I study for individuals 18-45 years of age who have been diagnosed with type 1 diabetes in the past 3-48 months. All participants will be treated with Proleukin (administered subcutaneously 3x per week) for 28 days and Rapamune (taken orally, daily) for 12 weeks. The study will last for 12 months, with additional follow-up of 24 months. The majority of study visits occur within the first 6 months. Mixed meal tolerance tests, in which participants take a milkshake-like drink and have blood sampled over a 2 or 4-hour period, will take place during an initial screening visit and three additional times during the first year. All participants will also receive intensive diabetes management designed to maintain stable blood glucose levels.


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.


Inclusion Criteria:

- Diagnosed with type 1 diabetes (per ADA criteria) more than 3 but less than 48 months

prior to enrollment

- Aged 18-45 years old

- 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


- 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

- participation in another clinical study within the last 30 days

Locations and Contacts

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

Additional Information

Immune Tolerance Network

Immune Tolerance Network (ITN) TrialShare: open public access to participant-level data available for this trial

Starting date: August 2007
Last updated: March 25, 2014

Page last updated: August 23, 2015

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