Targeting INflammation using SALsalate for Type 2 Diabetes

The National Institutes of Health–sponsored TINSAL-T2D (Targeting Inflammation Using Salsalate in Type 2 Diabetes) trials determine whether this generic and inexpensive drug is safe, tolerated, and efficacious in diabetes. Stage 1 was a dose-ranging study whereas stage 2 of TINSAL-T2D is a larger study to assess the magnitude and durability of glycemic efficacy over 1 year, tolerability, and an array of safety variables relevant to patients with diabetes. This trial evaluated glycemic effects of salicylate compared with placebo as add-on therapy for patients with inadequately treated, established T2DM. Salicylate is one of the oldest drugs in clinical practice, with documented use of relevant plant extracts for treating pain and inflammation dating back at least 3500 years. Nevertheless, its medicinal properties and mechanisms of action remain incompletely understood. When salicylate is acetylated by chemists, it yields aspirin. However, pure salicylate lacks an acetyl group and, thus, must have a different mechanism of action. Salicylate has not been tested previously for efficacy and safety under what regulatory agencies now consider to be current standard practice in clinical trials.