Evidence map›Paper›PMID 23817699›Full record

Trial reportAnnals of internal medicine2013

Salicylate (salsalate) in patients with type 2 diabetes: a randomized trial.

Allison B Goldfine, Vivian Fonseca, Kathleen A Jablonski, Yii-Der Ida Chen, Laura Tipton, Myrlene A Staten, Steven E Shoelson, Targeting Inflammation Using Salsalate in Type 2 Diabetes Study Team

5 registry-linked trialsAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of internal medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 127 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
127citing papers in PubMed, 5 pooled it
22.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00392678 phase2 / phase3completednot on this map

Targeting Inflammation in Type 2 Diabetes: Clinical Trial Using Salsalate

TypeinterventionalSponsorJoslin Diabetes CenterRan2006 to 2010Enrolled277ConditionsType 2 DiabetesArmsSalsalate, Placebo
NCT00624923 phase2 / phase3completednot on this map

Targeting Inflammation Using Salsalate in CardioVascular Disease (TINSAL-CVD)

TypeinterventionalSponsorJoslin Diabetes CenterRan2008 to 2016Enrolled340ConditionsCoronary Artery Disease, OverweightArmsSalsalate, Placebo
NCT00799643 phase2 / phase3completednot on this map

Targeting Inflammation in Type 2 Diabetes: Clinical Trial Using Salsalate

TypeinterventionalSponsorJoslin Diabetes CenterRan2008Enrolled638ConditionsType 2 Diabetes MellitusArmsSalsalate, Salsalate Placebo
NCT02422485 phase1completednot on this mapstarted 2015, after this paper: background citation

A 6 Month, Open-Label, Pilot Futility Clinical Trial of Oral Salsalate for Progressive Supranuclear Palsy

TypeinterventionalSponsorAdam BoxerRan2015 to 2019Enrolled10ConditionsProgressive Supranuclear PalsyArmsSalsalate
NCT03222206 phase4completednot on this mapstarted 2017, after this paper: background citation

The Comparison of Effect Between Salsalate and Placebo in Osteoarthritis With Nonalcoholic Fatty Liver Disease: Investigator Initiated Randomized Placebo-controlled Double-blind, Pilot Study

TypeinterventionalSponsorKorea University Guro HospitalRan2017 to 2019Enrolled34ConditionsNon Alcoholic Fatty Liver, Osteo ArthritisArmsSalsalate, Placebo
3 · Its place in the literature

Who cites it

127 citing papers in PubMed, 5 syntheses or guidelines pooled it, 248 citations in OpenAlex.

  1. Pooled it
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  8. C-C motif-ligand 2 inhibition with emapticap pegol (NOX-E36) in type 2 diabetic patients with albuminuria.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2017
    Trial
  9. Renal Toxicity Associated with Salsalate in Elderly Adults with Anemia.Journal of the American Geriatrics Society · 2016
    Trial
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  15. Interleukin-19 Regulates Adipose Tissue Dysfunction in Obesity: Interplay Between Inflammation and Vascularization.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2026
    Article
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67 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Allison B GoldfineJoslin Diabetes Center and Harvard Medical School, Boston, Massachusetts 02215, USA. allison.goldfine@joslin.harvard.edu
Vivian Fonseca
Kathleen A Jablonski
Yii-Der Ida Chen
Laura Tipton
Myrlene A Staten
Steven E Shoelson
Targeting Inflammation Using Salsalate in Type 2 Diabetes Study Team
Joslin Diabetes Center · US

Funding

Tracking & Evaluation CoreU54GM104940 · NIGMS · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · PI Leigh Lamonica · 2012 to 2026
$69.1M
UCLA Clinical and Translational Science InstituteUL1TR000124 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DUBINETT, STEVEN M. · 2012 to 2015
$57.0M
SPECIAL ASSAY COREP30DK036836 · NIDDK · JOSLIN DIABETES CENTER · PI ROHIT N. KULKARNI · 1986 to 2026
$50.5M
Transgenic & Knock-out MouseP30DK063491 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Andrea L Hevener · 2003 to 2026
$40.4M
Atlanta Clinical and Translational Science Institute (ACTSI) RenewalUL1TR000454 · NCATS · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2012 to 2016
$25.8M
Weight Loss, Inflammation, and Vascular RemodelingP50HL083813 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI WELTY, FRANCINE K · 2006 to 2015
$13.0M
Targeting Inflammation in Type 2 Diabetes: Clinical Trial Using SalsalateU01DK074556 · NIDDK · JOSLIN DIABETES CENTER · PI SHOELSON, STEVEN E · 2006 to 2010
$7.8M
Mechanism-Based Biomarkers for Glucose-Lowering in TINSAL-T2DRC4DK090792 · NIDDK · JOSLIN DIABETES CENTER · PI SHOELSON, STEVEN E · 2010 to 2010
$399k
NCATS NIH HHS UL1 TR000124NCATS NIH HHS UL1 TR000454NHLBI NIH HHS P50 HL083813NHLBI NIH HHS P50 HL83813NIDDK NIH HHS P30 DK036836NIDDK NIH HHS P30 DK03836NIDDK NIH HHS P30 DK063491NIDDK NIH HHS RC4 DK090792NIDDK NIH HHS U01 DK074556NIDDK NIH HHS U01 DK74556NIGMS NIH HHS U54 GM104940
6 · The paper itself

Abstract

backgroundShort-duration studies show that salsalate improves glycemia in type 2 diabetes mellitus (T2DM).

objectiveTo assess 1-year efficacy and safety of salsalate in T2DM.

designPlacebo-controlled, parallel trial; computerized randomization and centralized allocation, with patients, providers, and researchers blinded to assignment. (ClinicalTrials.gov: NCT00799643).

setting3 private practices and 18 academic centers in the United States. PATIENTS: Persons aged 18 to 75 years with fasting glucose levels of 12.5 mmol/L or less (≤225 mg/dL) and hemoglobin A1c (HbA1c) levels of 7.0% to 9.5% who were treated for diabetes.

intervention286 participants were randomly assigned (between January 2009 and July 2011) to 48 weeks of placebo (n = 140) or salsalate, 3.5 g/d (n = 146), in addition to current therapies, and 283 participants were analyzed (placebo, n = 137; salsalate, n = 146). MEASUREMENTS: Change in hemoglobin A1c level (primary outcome) and safety and efficacy measures.

resultsThe mean HbA1c level over 48 weeks was 0.37% lower in the salsalate group than in the placebo group (95% CI, -0.53% to -0.21%; P < 0.001). Glycemia improved despite more reductions in concomitant diabetes medications in salsalate recipients than in placebo recipients. Lower circulating leukocyte, neutrophil, and lymphocyte counts show the anti-inflammatory effects of salsalate. Adiponectin and hematocrit levels increased more and fasting glucose, uric acid, and triglyceride levels decreased with salsalate, but weight and low-density lipoprotein cholesterol levels also increased. Urinary albumin levels increased but reversed on discontinuation; estimated glomerular filtration rates were unchanged. LIMITATION: Trial duration and number of patients studied were insufficient to determine long-term risk-benefit of salsalate in T2DM.

conclusionSalsalate improves glycemia in patients with T2DM and decreases inflammatory mediators. Continued evaluation of mixed cardiorenal signals is warranted.

Indexed as

AdolescentAdultAgedAnti-Inflammatory Agents, Non-SteroidalBlood GlucoseDiabetes Mellitus, Type 2FemaleGlycated HemoglobinHumansKidneyMaleMiddle AgedSalicylatesSingle-Blind MethodYoung AdultAnti-Inflammatory Agents, Non-SteroidalBlood GlucoseGlycated HemoglobinSalicylatessalicylsalicylic acid

Identifiers

PMID23817699
PMCPMC4128629
OpenAlexW2031980199

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.