CLINICAL TRIAL: NEW ONSET OF TYPE 1 DIABETES MMF/DZB CLINICAL TRIAL

点击翻译按钮获取中文摘要

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The great body of evidence developed over the last 10-20 years suggests that Type 1 diabetes in humans is a chronic slowly progressive autoimmune disease. The objective of this study is to identify immune intervention strategies that will prevent the progression of beta cell destruction from the time of onset of type 1 diabetes. The persistence of at least some beta cells should improve long-term diabetes care and prevent not only complication of the disease itself, but also hypoglycemia, which is a consequence of its management. The aim is to arrest beta cell destruction in newly diabetic subjects because immune modulation may not work well alone once the autoimmune process has progressed to complete or near complete destruction of the beta cells. The study's rationale is to demonstrate a meaningful presentation of islet function with minimal immune system side effects over the 4-year course of this study. This study is a multi-center, three-arm, randomized, double masked, placebo-controlled clinical trial. Comparisons will be made among three groups: 1. Mycophenolate Mofetil (MMF) active drug with Daclizumab (DZB) placebo IV 2. MMF active drug with DZB active drug IV 3 MMF placebo with DZB placebo IV The primary outcome of each participant is his or her area under the stimulated C-peptide curve over the first two hours of a 4-hour mixed meal glucose tolerance test conducted at the two-year visit. Secondary outcomes are to examine how MMF alone or in conjunction with DZB affects the following: HbA1c, total number of hypoglycemia events, and number of major cases of hypoglycemic events. The data from this clinical trial could serve as the basis for a larger trial if the results are sufficiently positive, or they could suggest other combined intervention trials that might achieve either better efficacy or potentially preserve C-peptide without the need for continued immunosuppression.