Number of Subjects in Study Archive: 638
Study Design: Interventional
Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 2
Division: DEM
Duration: November 2008 – September 2012
# Recruitment Centers: 21
Treatment: Salsalate
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Clinical Trials URL:
https://clinicaltrials.gov/ct2/show/NCT00392678
Data Package Version Number: 2 (Updated on: May 17, 2016)
DOI: 10.58020/db9d-0n41
How to cite this dataset: Krischer, Jeffrey (2023). Targeting INflammation using SALsalate for Type 2 Diabetes (V2) [Dataset]. NIDDK Central Repository. https://doi.org/10.58020/db9d-0n41
Data availability statement: Data from the Targeting INflammation using SALsalate for Type 2 Diabetes [(V2)/https://doi.org/10.58020/db9d-0n41] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
The National Institutes of Health–sponsored TINSAL-T2D (Targeting Inflammation Using Salsalate in Type 2 Diabetes) trials determine whether this generic and inexpensive drug is safe, tolerated, and efficacious in diabetes. Stage 1 was a dose-ranging study whereas stage 2 of TINSAL-T2D is a larger study to assess the magnitude and durability of glycemic efficacy over 1 year, tolerability, and an array of safety variables relevant to patients with diabetes.
This trial evaluated glycemic effects of salicylate compared with placebo as add-on therapy for patients with inadequately treated, established T2DM. Salicylate is one of the oldest drugs in clinical practice, with documented use of relevant plant extracts for treating pain and inflammation dating back at least 3500 years. Nevertheless, its medicinal properties and mechanisms of action remain incompletely understood. When salicylate is acetylated by chemists, it yields aspirin. However, pure salicylate lacks an acetyl group and, thus, must have a different mechanism of action. Salicylate has not been tested previously for efficacy and safety under what regulatory agencies now consider to be current standard practice in clinical trials.
To assess 1-year efficacy and safety of salsalate treatment in patients with Type 2 Diabetes Mellitus.
Primary Outcome Measures:
Secondary Outcome Measures:
Inclusion Criteria:
Eligible adult patients between 18 and 75 who had hemoglobin A1c (HbA1c) levels of 7.0% to 9.5% at screening; and were treated by lifestyle modification or with metformin, insulin secretagogue, or dipeptidyl peptidase-4 inhibitor, alone or in combination.
Exclusion Criteria:
Participants younger than 18 or older than 75 years using insulin, thiazolidinediones, glucagon-like peptide-1 agonists, NSAIDs, warfarin, or uricosuric agents were not eligible.
Salsalate improves glycemia in patients with T2DM and decreases inflammatory mediators. Continued evaluation of mixed cardiorenal signals is warranted.