Proleukin and Rapamune in Type 1 Diabetes
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.
|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 ]
|Study Start Date:||August 2007|
|Estimated Study Completion Date:||September 2013|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
administered by subcutaneous injection at a dose of 4.5x106 IU/day, three times weekly for 28 days starting on day 0
Other Name: ProleukinDrug: 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 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.
|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|