Document Detail


The effects of salsalate on glycemic control in patients with type 2 diabetes: a randomized trial.
MedLine Citation:
PMID:  20231565     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Salsalate, a nonacetylated prodrug of salicylate, has been shown to decrease blood glucose concentration in small studies.
OBJECTIVE: To compare the efficacy and safety of salsalate at different doses in patients with type 2 diabetes.
DESIGN: Parallel 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)
SETTING: 3 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.
INTERVENTION: After 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.
RESULTS: Higher 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.
CONCLUSION: Salsalate 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.
Authors:
Allison B Goldfine; Vivian Fonseca; Kathleen A Jablonski; Laura Pyle; Myrlene A Staten; Steven E Shoelson;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Annals of internal medicine     Volume:  152     ISSN:  1539-3704     ISO Abbreviation:  Ann. Intern. Med.     Publication Date:  2010 Mar 
Date Detail:
Created Date:  2010-03-16     Completed Date:  2010-04-15     Revised Date:  2014-09-24    
Medline Journal Info:
Nlm Unique ID:  0372351     Medline TA:  Ann Intern Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  346-57     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00392678
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Albuminuria / chemically induced
Blood Glucose / metabolism*
Diabetes Mellitus, Type 2 / blood*,  drug therapy*
Double-Blind Method
Female
Gastrointestinal Diseases / chemically induced
Hemoglobin A, Glycosylated / metabolism
Humans
Hypoglycemic Agents / administration & dosage*,  adverse effects
Lipids / blood
Male
Middle Aged
Prodrugs / administration & dosage*,  adverse effects
Salicylates / administration & dosage*,  adverse effects
Tinnitus / chemically induced
Young Adult
Grant Support
ID/Acronym/Agency:
M01 RR001032/RR/NCRR NIH HHS; M01 RR002635/RR/NCRR NIH HHS; P30 DK036836/DK/NIDDK NIH HHS; P50 HL83813/HL/NHLBI NIH HHS; U01 DK074556/DK/NIDDK NIH HHS; U01 DK074556-01/DK/NIDDK NIH HHS; U01 DK74556/DK/NIDDK NIH HHS; UL1 RR025008/RR/NCRR NIH HHS
Chemical
Reg. No./Substance:
0/Blood Glucose; 0/Hemoglobin A, Glycosylated; 0/Hypoglycemic Agents; 0/Lipids; 0/Prodrugs; 0/Salicylates; 552-94-3/salicylsalicylic acid
Investigator
Investigator/Affiliation:
Joshua Barzilay / ; Susan Braithwaite / ; Wayman Wendell Cheatham / ; Jill Crandell / ; Paresh Dandona / ; Cyrus Desouza / ; Daniel Donovan / ; Vivian Fonseca / ; Allison Goldfine / ; Kenneth Hershon / ; Theodore Mazzone / ; Janet McGill / ; Victor Lawrence Roberts / ; Guillermo Umpierrez / ; Wayne Warren / ; Steven Wittlin / ; Kathleen Wyne /
Comments/Corrections
Summary for patients in:
Ann Intern Med. 2010 Mar 16;152(6):I-40   [PMID:  20231550 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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