TARGETING INFLAMMATION USING SALSALATE FOR TYPE 2 DM

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 TINSAL-T2D研究的主要结果是，在最后一次观察的基础上，意向治疗(ITT)人群的HbA1c水平从基线到第26周的变化。ITT人群被定义为具有至少一次基线后HbA1c测量并至少服用一剂随机研究药物的任何患者。ITT和可评价人群的重要次要结果包括： 从基线改变为抢救治疗前26周或最后一次HbA1c测定 糖化血红蛋白随时间的变化趋势 空腹血糖较基线的变化和随时间的变化趋势 空腹血糖下降=20毫克/分升，糖化血红蛋白下降=0.5%，糖化血红蛋白下降=0.8%的应答率 血脂(低密度脂蛋白胆固醇、非高密度脂蛋白胆固醇、甘油三酯、总胆固醇、高密度脂蛋白胆固醇、总胆固醇/高密度脂蛋白胆固醇、低密度脂蛋白胆固醇/高密度脂蛋白胆固醇、低密度脂蛋白胆固醇/高密度脂蛋白胆固醇) 胰岛素敏感性的变化(胰岛素、C肽、稳态模型[HOMA]指数) 活动组和安慰剂组之间超过高血糖目标的应答率 抢救治疗的必要性 是否需要停止研究用药 最初接受生活方式改变、胰岛素促分泌剂、二甲双胍或联合治疗的患者的应答率 肥胖者与非肥胖者糖化血红蛋白降低的应答率 水杨酸盐与安慰剂的安全性和耐受性比较

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