Home
Search
Study Topics
Glossary
|
Study 5 of 174 for search of: | Open Studies | "Diabetes Mellitus, Type 1" |
Previous Study | Return to Search Results | Next Study |
|
|
|
|
|
Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network |
---|---|
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00525889 |
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 I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I Trial of Proleukin and Rapamune in Recent-Onset Type 1 Diabetes Mellitus |
Estimated Enrollment: | 10 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | September 2012 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
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
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
|
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) for 28 days and Rapamune (taken orally) for 12 weeks. The study will last for 12 months, with possible additional follow-up of 24 months. Mixed meal tolerance tests, in which participants take a milkshake-like drink and have blood sampled over a 2-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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Laurie Allen | (206) 223-8865 | lallen@benaroyaresearch.org |
Contact: Marli McCulloch-Olson | 877-277-2234 | diabetes@benaroyaresearch.org |
United States, New York | |
Naomi Berrie Diabetes Center, Columbia University | Recruiting |
New York, New York, United States, 10032 | |
Contact: Ellen Greenberg, MS 212-851-5425 emg25@columbia.edu | |
Principal Investigator: Robin Goland, MD | |
United States, Washington | |
Benaroya Research Institute | Recruiting |
Seattle, Washington, United States, 98101 | |
Contact: Laurie Allen 206-223-8865 lallen@benaroyaresearch.org | |
Contact: Marli McCulloch-Olson 877-277-2234 diabetes@benaroyaresearch.org | |
Principal Investigator: Carla Greenbaum, MD |
Principal Investigator: | Carla Greenbaum, MD | Benaroya Research Institute |
Responsible Party: | DAIT/NIAID ( Associate Director, Clinical Research Program ) |
Study ID Numbers: | ITN018AI |
Study First Received: | September 4, 2007 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00525889 |
Health Authority: | United States: Federal Government |
diabetes juvenile diabetes type 1 diabetes |
diabetes mellitus recent onset new onset |
Sirolimus Metabolic Diseases Autoimmune Diseases Clotrimazole Miconazole Diabetes mellitus type 1 Tioconazole Diabetes Mellitus |
Benzocaine Endocrine System Diseases Aldesleukin Diabetes Mellitus, Type 1 Endocrinopathy Glucose Metabolism Disorders Metabolic disorder |
Anti-Infective Agents Anti-HIV Agents Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Anti-Bacterial Agents Anti-Retroviral Agents Therapeutic Uses Antifungal Agents |