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Targeting Inflammation With Salsalate in Type 1 Diabetes Neuropathy

NCT02936843 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-05-16

Study results available
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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.

Conditions

Interventions

DRUG

Salsalate

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

DRUG

PLACEBO

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

Sponsors & Collaborators

Principal Investigators

  • Rodica Pop-Busui, MD, PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2023-05-01
Completion
2023-05-01

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02936843 on ClinicalTrials.gov