| Outcome Measures: |
Primary: Change in HbA1c Baseline to End of Trial in TINSAL-T2D Stage 1, The primary outcome for the TINSAL-T2D study is change in HbA1c level from baseline to week 14 (stage 1) in the intent-to-treat (ITT) population with last observation carried forward., 14 week | Secondary: Change in HbA1c, Change from baseline to either 14 or 26 weeks, or last HbA1c measurement prior to rescue therapy, 14 week|Change From Baseline and Trends in Fasting Glucose Over Time, 14 week|Change in Lipids, 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) LDL-C/HDL-C ratio not calculated, 14 week|Change From Baseline in 14-week Insulin, C-peptide, Homeostasis Model [HOMA] Index, HOMA-IR was not calcuated due to potential confounding effect of salicylates to inhibit insulin clearance. Change in insulin from Baseline to Week 14 in data table below., Baseline, week 14|Safety and Tolerability, See adverse event module for details. Safety and tolerability of salsalate compared to placebo as assessed by adverse events., 14 weeks|Change in Insulin, C-peptide, Homeostasis Model [HOMA] Index, HOMA-IR was not calcuated due to potential confounding effect of salicylates to inhibit insulin clearance. Change in C-peptide from Baseline to Week 14 is in the data table below, Baseline, week 14
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| Locations: |
Chapel Medical Group, New Haven, Connecticut, 06511, United States|MedStar Research Institute, Washington, District of Columbia, 20003-4393, United States|Endocrine Clinical Research, Winter Park, Florida, 32746, United States|Kaiser Permanente, Atlanta, Georgia, 30084, United States|Emory School of Medicine, Atlanta, Georgia, 30303, United States|University of Illinois at Chicago, Chicago, Illinois, 60612, United States|Tulane University, New Orleans, Louisiana, 70112, United States|Joslin Diabetes Center, Boston, Massachusetts, 02215, United States|Washington University School of Medicine, Saint Louis, Missouri, 63110, United States|University of Nebraska Medical Center, Omaha, Nebraska, 68105, United States|Kaleida Health Center, Buffalo, New York, 14226, United States|North Shore Diabetes and Endocrine Associates, New Hyde Park, New York, 11042, United States|Columbia University, New York, New York, 10032, United States|University of Rochester Medical Center, Rochester, New York, 14642, United States|University of North Carolina, Chapel Hill, North Carolina, 27599, United States|University of Texas Southwestern, Dallas, Texas, 75390, United States
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