Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes Inflammation Obesity Metabolic Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 277
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. 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.

Detailed description:
The primary objective of the first stage of the TINSAL-T2D trial is to select a dose of salsalate that is both well-tolerated and demonstrates a trend toward improvement in glycemic control. The trial is a multicenter, single mask lead-in, double masked placebo controlled dose ranging study, comparing salsalte to placebo over 3 months.

Arms:
arm 1: Placebo, appearance matched to active drug arm 2: Salsalate 3.0 grams daily, divided arm 3: Salsalate 3.5 g daily, divided arm 4: Salsalate 4.0 g daily, divided

Interventions: intervention 1: Salsalate intervention 2: Placebo
Intervention descriptions: intervention 1: Placebo and Salsalate 3.0 g/d; 3.5 g/d; 4.0 g/d orally, divided intervention 2: Placebo to Salsalate

Protocol document: