PHASE II MULTIPLE-DOSE TREATMENT OF TYPE 1 DIABETES MELLITUS

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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. This is a multi-centered, 2 arm, randomized, open label, Phase II trial involving 0 or 2 cycles of treatment one year apart using the immune suppressive drug hOKT3yl (Ala-Ala) in patients with new onset type 1 Diabetes Mellitus (T1DM). It is hypothesized that hOKT3 will arrest the loss of insulin production of the pancreatic beta cells during the first 2 years from diagnosis and improve glycemic control. Greater glycemic control has been shown to result in less long-term TIDM morbidity. Participants will be randomized to drug treatment (Group A) or control (Group B). There is dose escalation within each cycle, but no change between cycles. The randomization will be 2 drug subjects to 1 control subject and will be stratified by study site. The current protocol is based on Phase I/II and PK/Safety trials conducted at Columbia University that suggested clinical efficacy as published in the NEJM in May 2002, and demonstrated safety of the drug.