This is a phase I trial testing whether two immune system modifying drugs are safe when used in combination and if they can alter the immune system in a way that shows they can halt the progression of type 1 diabetes. This study is for patients who have been diagnosed within the past 3-48 months.
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. |
