drugset / Trial / NCT02936843

Targeting Inflammation With Salsalate in Type 1 Diabetes Neuropathy

NCT02936843

Phase 2/3 Completed 61 enrolled University of Michigan
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Diabetic neuropathy (DN) is the most common chronic complication of diabetes, affecting up to50% of individuals with type 1 diabetes (T1DM). Multiple pre-clinical and clinical studies demonstrate a pathogenic role for inflammation, especially cytokine production, in the disease course of DN and CAN. This suggests that agents with known anti-inflammatory properties, such as salicylates, may prevent the development of DN and the pain associated with DN. This study builds upon and expands on prior work done by the investigators with salsalate, a pro-drug form of salicylate, as an agent to address inflammatory pathways in people with T1DM.

Timeline

Start
2016-10
Primary completion
2023-05-01
Completion
2023-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Salsalate Small molecule 1 g Oral