At a glance
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Targeting Inflammation in Type 2 Diabetes: Clinical Trial Using Salsalate
In Brief
A Phase 3 clinical trial evaluating Salsalate and Salsalate Placebo for Type 2 Diabetes Mellitus. Completed, enrolled 638 participants across 21 sites.
Detailed Summary
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. Enrollment in the first stage is complete. The primary objective of the first stage was to select a dose of salsalate that is both well-tolerated and demonstrates a trend toward improvement in glycemic control. 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.
Study Details
Timeline
Interventions
Salsalate 3.5 g/d orally, divided dosing