Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus (T2D) Inflammation Obesity Metabolic Syndrome Salicylates
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 638
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Salsalate, 3.5 g/d orally, divided dosing arm 2: Salsalate Placebo, orally, divided dosing

Interventions: intervention 1: Salsalate intervention 2: Salsalate Placebo
Intervention descriptions: intervention 1: Salsalate 3.5 g/d orally, divided dosing intervention 2: None

Protocol document: