NCT00799643

Targeting Inflammation Using Salsalate for Type 2 Diabetes-Stage II

Targeting Inflammation in Type 2 Diabetes: Clinical Trial Using Salsalate

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 638 (actual)
• Sponsor: Joslin Diabetes Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Salsalate	Salsalate 3.5 g/d orally, divided dosing
DRUG	Salsalate Placebo

Timeline

• Start date: 2008-11-01
• Primary completion: 2012-09-01
• First posted: 2008-12-01
• Last updated: 2017-12-11
• Results posted: 2013-11-25

Locations

21 sites across 1 country: United States