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

Goldfine AB, Fonseca V, Jablonski KA, Pyle L, Staten MA, Shoelson SE; for the TINSAL-T2D Study Team.
Ann Intern Med. 2010;152:346-357. 

This overview was created by KnowledgePoint360 Group, LLC, and was not associated with funding via an educational grant or a promotional interest. 

The Targeting Inflammation Using Salsalate* in Type 2 Diabetes (TINSAL-T2D) trial was a parallel, randomized, placebo-controlled multicenter trial evaluating the safety and efficacy of salsalate in subjects with type 2 diabetes.  

Eligible subjects met the following criteria: aged 18–75 years, type 2 diabetes duration: ≥8 weeks, fasting plasma glucose ≤225 mg/dL, A1C 7.0% to 9.5% at screening, and treatment by diet and exercise alone or with metformin, insulin secretagogue, or dipeptidyl peptidase-4 inhibitor, either as mono- or combination therapy at a stable dose for ≥8 weeks.  

The study protocol was as follows: 1-week screening, 4-week single-masked placebo run-in, pretreatment baseline evaluation, and 14-week treatment (consisting of visits at weeks 2, 4, 8, and 14 after randomization). Subjects were randomized to one of four groups (n=27 in each group) for the treatment period:  

  • Salsalate 3.0 g/day  
  • Salsalate 3.5 g/day  
  • Salsalate 4.0 g/day  
  • Placebo  

Treatments were divided into 3 daily doses and were escalated in 0.5-g/day increments over 2-week intervals for subjects in the higher dosage groups. Adherence to the treatment regimen was assessed via pill count.  

The study’s primary outcome was change in A1C. Secondary outcomes included adverse events and changes in measures of coronary risk and renal function.  

Results:
Changes in A1C from baseline, the study’s primary endpoint, were observed as follows in each of the treatment groups:  

  • Salsalate 3.0 g/day: -0.4 (95% confidence interval [CI], -0.6 to -0.2); P=0.017  
  • Salsalate 3.5 g/day: -0.3 (95% CI, -0.5 to -0.2); P=0.017  
  • Salsalate 4.0 g/day: -0.5 (95% CI, -0.7 to -0.3); P=0.001  
  • Placebo: 0.0 (95% CI, -0.2 to 0.2)  

A greater proportion of salsalate-treated subjects had A1C decreases of ≥0.5% from baseline (P=0.009 for difference).  

Changes in fasting glucose concentration from baseline were observed as follows in each of the treatment groups:  

  • Salsalate 3.0 g/day: -19 (95% confidence interval [CI], -30 to -8)  
  • Salsalate 3.5 g/day: -14 (95% CI, -25 to -3)  
  • Salsalate 4.0 g/day: -15 (95% CI, -26 to -4)  
  • Placebo: 13 (95% CI, 2 to 24)  

*Salsalate is a generic compound that is not used to treat diabetes   

Don’t miss slides on the TINSAL-T2D trial in our Slide Library: 

TINSAL-T2D Trial: Design 

TINSAL-T2D Trial: Eligibility Criteria and Study Protocol 

TINSAL-T2D Trial: Baseline Characteristics 

TINSAL-T2D Trial: Primary Outcome—Change in A1C 

TINSAL-T2D Trial: Change in Fasting Glucose Concentration 

 This overview was created by KnowledgePoint360 Group, LLC, and was not associated with funding via an educational grant or a promotional interest. 

 

Last Modified: 11/18/2013