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.

近年来越来越多的研究证据表明，低度慢性炎症在胰岛素抵抗与2型糖尿病的发病机制中可能发挥潜在作用。本研究旨在探讨双水杨酸酯（salsalate）——临床常用非甾体抗炎药（Non-Steroidal Anti-Inflammatory Drug, NSAID）类药物之一——是否可有效降低2型糖尿病患者的血糖水平，同时明确水杨酸盐类药物能否为糖尿病管理提供全新的药理学治疗选择。本研究分为两个阶段开展。第一阶段为剂量探索研究，为期三个月，受试者将被给予双水杨酸酯与安慰剂进行对照干预。本研究第二阶段的主要研究目标包括：评估双水杨酸酯对糖尿病患者血糖控制的影响；考察2型糖尿病（T2D）患者使用双水杨酸酯的耐受性；以及分析双水杨酸酯对炎症指标、代谢综合征及心血管风险相关指标的作用。第二阶段为另一项独立临床试验，已通过备用注册流程备案。