Evidence map›Paper›PMID 20231565›Full record

Trial reportAnnals of internal medicine2010

The effects of salsalate on glycemic control in patients with type 2 diabetes: a randomized trial.

Allison B Goldfine, Vivian Fonseca, Kathleen A Jablonski, Laura Pyle, Myrlene A Staten, Steven E Shoelson, TINSAL-T2D (Targeting Inflammation Using Salsalate in Type 2 Diabetes) Study Team

5 registry-linked trialsOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of internal medicine, 2010. 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 203 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
203citing papers in PubMed, 6 pooled it
28.3field-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
NCT01775865 phase2completednot on this mapstarted 2012, after this paper: background citation

Targeting Inflammation to Treat Cardiovascular Aging in Humans (TIVA Study)

TypeinterventionalSponsorGary L. PierceRan2012 to 2016Enrolled59ConditionsVascular Stiffness, Endothelial Dysfunction, Diastolic DysfunctionArmsSalsalate, Placebo (for salsalate)
NCT02130804 phase1completednot on this mapstarted 2011, after this paper: background citation

Using Salsalate to Target Adipocyte Macrophage Infiltration and Reverse Metabolic Disease Risk in Obese Hispanic Young Adults

TypeinterventionalSponsorUniversity of Southern CaliforniaRan2011 to 2013Enrolled30ConditionsDiabetes RiskArmsSalsalate (4 g/day), Placebo (4 g/day)
3 · Its place in the literature

Who cites it

203 citing papers in PubMed, 6 syntheses or guidelines pooled it, 385 citations in OpenAlex.

  1. Pooled it
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  3. Type 2 Diabetes: How Much of an Autoimmune Disease?Frontiers in endocrinology · 2019
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  6. A meta-analysis of salicylates for type 2 diabetes mellitus.Journal of Huazhong University of Science and Technology. Medical sciences = Hua zhong ke ji da xue xue bao. Yi xue Ying De wen ban = Huazhong keji daxue xuebao. Yixue Yingdewen ban · 2013
    Pooled it
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143 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Allison B GoldfineJoslin Diabetes Center and Harvard Medical School, Boston, Massachusetts 02215, USA.
Vivian Fonseca
Kathleen A Jablonski
Laura Pyle
Myrlene A Staten
Steven E Shoelson
TINSAL-T2D (Targeting Inflammation Using Salsalate in Type 2 Diabetes) Study Team
Tulane University · US

Funding

Zoledronic Acid in Treatment of Osteoporosis in PostmenoM01RR002635 · NCRR · BRIGHAM AND WOMEN'S HOSPITAL · PI WILLIAMS, GORDON H · 1985 to 2008
$48.4M
ZINC STATUS AND T CELL DISORDER IN MILD HUMAN ZINC DEFICIENCYM01RR001032 · NCRR · BETH ISRAEL DEACONESS MEDICAL CENTER · PI PASCUAL-LEONE, ALVARO · 1985 to 2008
$32.3M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025008 · NCRR · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2007 to 2011
$29.0M
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
NCATS NIH HHS UL1 TR000454NCRR NIH HHS M01 RR001032NCRR NIH HHS M01 RR002635NCRR NIH HHS UL1 RR025008NHLBI NIH HHS P50 HL083813NHLBI NIH HHS P50 HL83813NIDDK NIH HHS U01 DK074556NIDDK NIH HHS U01 DK74556
6 · The paper itself

Abstract

backgroundSalsalate, a nonacetylated prodrug of salicylate, has been shown to decrease blood glucose concentration in small studies.

objectiveTo compare the efficacy and safety of salsalate at different doses in patients with type 2 diabetes.

designParallel randomized trial with computer-generated randomization and centralized allocation. Patients and investigators, including those assessing outcomes and performing analyses, were masked to group assignment. (ClinicalTrials.gov registration number: NCT00392678)

setting3 private practices and 14 universities in the United States. PATIENTS: Persons aged 18 to 75 years with fasting plasma glucose concentrations of 12.5 mmol/L or less (< or = 225 mg/dL) and hemoglobin A1c (HbA1c) levels of 7.0% to 9.5% treated by diet, exercise, and oral medication at stable doses for at least 8 weeks.

interventionAfter a 4-week, single-masked run-in period, patients were randomly assigned to receive placebo or salsalate in dosages of 3.0, 3.5, or 4.0 g/d for 14 weeks (27 patients each) in addition to their current therapy. MEASUREMENTS: Change in HbA1c was the primary outcome. Adverse effects and changes in measures of coronary risk and renal function were secondary outcomes.

resultsHigher proportions of patients in the 3 salsalate treatment groups experienced decreases in HbA1c levels of 0.5% or more from baseline (P = 0.009). Mean HbA1c changes were -0.36% (P = 0.02) at 3.0 g/d, -0.34% (P = 0.02) at 3.5 g/d, and -0.49% (P = 0.001) at 4.0 g/d compared with placebo. Other markers of glycemic control also improved in the 3 salsalate groups, as did circulating triglyceride and adiponectin concentrations. Mild hypoglycemia was more common with salsalate; documented events occurred only in patients taking sulfonylureas. Urine albumin concentrations increased in all salsalate groups compared with placebo. The drug was otherwise well tolerated. LIMITATION: The number of patients studied and the trial duration were insufficient to warrant recommending the use of salsalate for type 2 diabetes at this time.

conclusionSalsalate lowers HbA1c levels and improves other markers of glycemic control in patients with type 2 diabetes and may therefore provide a new avenue for treatment. Renal and cardiac safety of the drug require further evaluation. PRIMARY FUNDING SOURCE: National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health.

Indexed as

AdolescentAdultAgedAlbuminuriaBlood GlucoseDiabetes Mellitus, Type 2Double-Blind MethodFemaleGastrointestinal DiseasesGlycated HemoglobinHumansHypoglycemic AgentsLipidsMaleMiddle AgedProdrugsBlood GlucoseGlycated HemoglobinHypoglycemic AgentsLipidsProdrugsSalicylatessalicylsalicylic acid

Identifiers

PMID20231565
PMCPMC3138470
OpenAlexW1967724716

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.