Proleukin and Rapamune in Type 1 Diabetes
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 1 |
Drug: IL-2 Drug: sirolimus |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Trial of Proleukin and Rapamune in Recent-onset Type 1 Diabetes Mellitus (ITN018AI) |
- incidence and severity of adverse events and laboratory anomalies [ Time Frame: through day 364 ] [ Designated as safety issue: Yes ]
- AUC for c-peptide responses following MMTT [ Time Frame: various ] [ Designated as safety issue: No ]
- frequency of severe hypoglycemia [ Time Frame: various ] [ Designated as safety issue: Yes ]
- insulin dose in units per kilogram [ Time Frame: various ] [ Designated as safety issue: No ]
- HbA1c levels [ Time Frame: various ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 10 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | September 2013 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: IL-2
administered by subcutaneous injection at a dose of 4.5x106 IU/day, three times weekly for 28 days starting on day 0
Other Name: Proleukin
Drug: sirolimus
administered orally, initial daily dose of 2mg PO. At day 7, dose adjusted to achieve and maintain whole blood trough levels of 5-10 ng/ml
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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
- participation in another clinical study within the last 30 days
Contacts and Locations| United States, New York | |
| Naomi Berrie Diabetes Center, Columbia University | |
| New York, New York, United States, 10032 | |
| United States, Oregon | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States, 97239 | |
| United States, Washington | |
| Benaroya Research Institute | |
| Seattle, Washington, United States, 98101 | |
| Principal Investigator: | Carla Greenbaum, MD | Benaroya Research Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00525889 History of Changes |
| Other Study ID Numbers: | DAIT ITN018AI |
| Study First Received: | September 4, 2007 |
| Last Updated: | July 12, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
diabetes juvenile diabetes type 1 diabetes |
diabetes mellitus recent onset new onset |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Sirolimus Everolimus Aldesleukin Antibiotics, Antineoplastic Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents |
ClinicalTrials.gov processed this record on May 16, 2013