CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 61 enrolled
Drug / intervention
Salsalate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02936843
NCT02936843Phase 3Completed
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Targeting Inflammation With Salsalate in Type 1 Diabetes Neuropathy-TINSAL -T1DN

University of Michigan·interventional·Posted Oct 18, 2016·Updated May 16, 2025

In Brief

A Phase 3 clinical trial evaluating Salsalate and PLACEBO for Type 1 Diabetes and Peripheral Neuropathy. Completed, enrolled 61 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes, Peripheral Neuropathy
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 18, 2016
Enrollment StartOct 1, 2016
Primary CompletionMay 1, 2023
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 9.7 years ago

Interventions

Salsalatedrug

1 gram, 3 times daily by mouth (total of 3 grams daily)

PLACEBOdrug

Placebo for Salsalate; 2 Tablets, 3 times daily by mouth (total of 3 grams daily)