Principal Investigator:
Kathleen Jablonski, Ph.D.

he 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 & Digestive & Kidney Diseases (NIDDK) Cooperative
Agreement 1-U01-DK074556-01, 2006-2009.
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