• Register
X
Forgot Password

If you have forgotten your password you can enter your email here and get a temporary password sent to your email.

X

Leaving Community

Are you sure you want to leave this community? Leaving the community will revoke any permissions you have been granted in this community.

No
Yes

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

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.

Pubmed ID: 20231565

Authors

  • Goldfine AB
  • Fonseca V
  • Jablonski KA
  • Pyle L
  • Staten MA
  • Shoelson SE
  • TINSAL-T2D (Targeting Inflammation Using Salsalate in Type 2 Diabetes) Study Team

Journal

Annals of internal medicine

Publication Data

March 16, 2010

Associated Grants

  • Agency: NCRR NIH HHS, Id: M01 RR001032
  • Agency: NCRR NIH HHS, Id: M01 RR002635
  • Agency: NHLBI NIH HHS, Id: P50 HL83813
  • Agency: NIDDK NIH HHS, Id: U01 DK074556
  • Agency: NIDDK NIH HHS, Id: U01 DK074556-01
  • Agency: NIDDK NIH HHS, Id: U01 DK74556
  • Agency: NCRR NIH HHS, Id: UL1 RR025008
  • Agency: NCATS NIH HHS, Id: UL1 TR000454

Mesh Terms

  • Adolescent
  • Adult
  • Aged
  • Albuminuria
  • Blood Glucose
  • Diabetes Mellitus, Type 2
  • Double-Blind Method
  • Female
  • Gastrointestinal Diseases
  • Hemoglobin A, Glycosylated
  • Humans
  • Hypoglycemic Agents
  • Lipids
  • Male
  • Middle Aged
  • Prodrugs
  • Salicylates
  • Tinnitus
  • Young Adult