Dataset from Targeting Inflammation in Type 2 Diabetes: Clinical Trial Using Salsalate

Growing evidence over recent years supports a potential role for low grade chronic
inflammation in the pathogenesis of insulin resistance and type 2 diabetes. In this study we
will determine whether salsalate, a member of the commonly used Non-Steroidal
Anti-Inflammatory Drug (NSAID) class, is effective in lowering sugars in patients with type 2
diabetes. The study will determine whether salicylates represent a new pharmacological option
for diabetes management. The study is conducted in two stages. The first stage is a dose
ranging study, administering salsalate compared to placebo over three months. The primary
objective of Stage 2 of the study is to evaluate the effects of salsalate on blood sugar
control in diabetes; the tolerability of salsalate use in patients with type 2 diabetes
(T2D); and the effects of salsalate on measures of inflammation, the metabolic syndrome, and
cardiac risk.

The second stage is a second trial and posted under alternate registration.