TARGETING INFLAMMATION USING SALSALATE IN TYPE 2 DIABETES (TINSAL-T2D)
Principal Investigator: Kathleen Jablonski, Ph.D.
The Biostatistics Center serves as the Coordinating Center for the Targeting Inflammation Using Salsalate for Type 2 Diabetes Study (TINSAL-T2D). This study is a multi-center, randomized, double-masked, placebo-controlled, parallel-group clinical treatment trial. The primary objective of the study is to determine whether salicylates represent a new pharmacological option for diabetes management. This new study is in the first of two stages. The primary objective of stage one is to select a dose of salsalate that is both well-tolerated and demonstrates a trend toward improvement in glycemic control. The implementation of the second stage is predicated on the successful selection of a dose in the first stage. If no dose meets the criteria for continuation to Stage 2, the study will end after Stage 1. The primary objective of Stage 2 of the study will be 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. Funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Cooperative Agreement 1-U01-DK074556-01, 2006-2009.)