NCT00392678

Targeting INflammation Using SALsalate in Type 2 Diabetes (TINSAL-T2D)

Targeting Inflammation in Type 2 Diabetes: Clinical Trial Using Salsalate

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 277 (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. 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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Salsalate	Placebo and Salsalate 3.0 g/d; 3.5 g/d; 4.0 g/d orally, divided
DRUG	Placebo	Placebo to Salsalate

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-07-01
• Completion: 2010-12-01
• First posted: 2006-10-26
• Last updated: 2019-04-08
• Results posted: 2013-07-26

Locations

16 sites across 1 country: United States