TARGETING INFLAMMATION USING SALSALATE FOR TYPE 2 DIABETES STAGE II

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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. Introduction and Rationale The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) has sponsored a collaborative agreement to conduct a clinical treatment trial, entitled Targeting Inflammation Using Salsalate for Type 2 Diabetes (TINSAL-T2D). The trial is conducted in two stages. Stage I was completed and presented to the DSMB on July 24, 2008. This protocol describes the background, design and organization of Stage II of the trial. The protocol was written by the members of the TINSAL-T2D Study Group, approved by an External Advisory Board, and approved by the Institutional Review Boards (IRB's) of each participating clinical center prior to the initiation of recruitment. The Steering Committee for the TINSAL-T2D Study Group is composed of investigators at Joslin Diabetes Center, Tulane Univeristy, the George Washington University Biostatistics Center, and the NIDDK project office. Detailed study procedures are provided in the study's manual of procedures (MOP). Specific Aims and Objectives The primary objective of the study is to determine whether salicylates represent a new pharmacologial option for diabetes management. The study is conducted in two stages. The primary objective of the first stage was to select a dose of salsalate that was both well-tolerated and demonstrated a trend toward improvement in glycemic control. The primary objective of Stage II of the study is to evaluate: the effects of salsalate on glycemic control in diabetes; the tolerability of salsalate use in patients with type 2 diabetes (T2D); and the effects of salsalate on measures of inflammation, the metabolic syndrome, and cardiac risk