TARGETING INFLAMMATION USING SALSALATE FOR TYPE 2 DM

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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. The primary outcome for the TINSAL-T2D study is change in HbA1c level from baseline to week 26 in the intent-to-treat (ITT) population with last observation carried forward. The ITT population is defined as any patient who has at least one post-baseline measurement of HbA1c and has taken at least one dose of the randomized study drug. Important secondary outcomes for both the ITT and evaluable populations include: Change from baseline to either 26 weeks or last HbA1c measurement prior to rescue therapy Trends in HbA1c over time Change from baseline and trends in fasting glucose over time Response rates for reduction in fasting glucose of =20 mg/dl, a reduction in HbA1c of =0.5%, and a reduction in HbA1c of =0.8% Change in lipids (low-density lipoprotein cholesterol [LDL-C], non-high-density lipoprotein cholesterol [non-HDL-C], triglycerides [TG], total cholesterol [TC], high-density lipoprotein cholesterol [HDL C], TC/HDL-C ratio, and LDL-C/HDL-C ratio) Change in insulin sensitivity (insulin, C-peptide, homeostasis model [HOMA] index) Response rates for exceeding hyperglycemic targets between active and placebo treated groups Need for rescue therapy Need for discontinuation of study medication Response rates in patients initially treated with lifestyle modification, insulin secretagogue, metformin or combination therapy Response rates for a reduction in HbA1c for obese vs non-obese participants Safety and tolerability of salsalate compared to placebo