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Nonsteroidal Anti-inflammatory Drug

Salsalate for Peripheral Neuropathy (TINSAL-T1DN Trial)

Phase 2 & 3
Waitlist Available
Led By Rodica Pop-Busui, MD, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
T1DM
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

TINSAL-T1DN Trial Summary

This trial will study whether salsalate can help prevent or delay the development of diabetic neuropathy in people with type 1 diabetes.

Eligible Conditions
  • Peripheral Neuropathy
  • Type 1 Diabetes

TINSAL-T1DN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have Type 1 Diabetes Mellitus (T1DM).

TINSAL-T1DN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Skin Biopsy - Intraepidermal Nerve Fiber Density (IENFD) - Distal Thigh

TINSAL-T1DN Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SalsalateExperimental Treatment1 Intervention
Salsalate, 1 gram by mouth, 3 times daily (3 grams per day) for 12 months.
Group II: ComparatorPlacebo Group1 Intervention
Placebo for Salsalate, 2 tablets by mouth, 3 times daily for 12 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Salsalate
2007
Completed Phase 4
~1650

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,786 Previous Clinical Trials
6,365,461 Total Patients Enrolled
1 Trials studying Peripheral Neuropathy
8 Patients Enrolled for Peripheral Neuropathy
Rodica Pop-Busui, MD, PhDPrincipal Investigator - University of Michigan
University of Michigan
4 Previous Clinical Trials
154 Total Patients Enrolled
1 Trials studying Peripheral Neuropathy
8 Patients Enrolled for Peripheral Neuropathy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being accepted into this trial at the current time?

"That is correct, the online information indicates that the study is still looking for subjects. The trial was originally posted on October 1st, 2016 and was most recently updated June 1st of this year. They are hoping to enroll 70 individuals at 3 different locations."

Answered by AI

Are elderly patients a part of this research program?

"This trial is only taking applications from patients aged 18 to 70. Out of the qualifications trials, this one is for people in the middle-age bracket. There are 256 trials specifically for children and 1391 research studies available for senior citizens."

Answered by AI

What is the biggest amount of people who are taking part in this experiment?

"The data on clinicaltrials.gov does show that this study is recruiting patients. The trial was originally posted on October 1, 2016 and the most recent update was on June 1, 2022. They are hoping to enroll 70 people total at 3 different sites."

Answered by AI

What is the precedent for Salsalate research?

"At the moment, there are 5 different ongoing studies for Salsalate. 1 of these live trials is in its final stage of testing before commercial release. Even though most research is based out of Ann Arbor, Michigan; there are actually 10 locations running active trials."

Answered by AI

Are there specific requirements to be a part of this clinical trial?

"This study is investigating a possible treatment for peripheral neuropathy and is looking for around 70 participants that are between 18 and 70 years old."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What site did they apply to?
University of Michigan Health System
What portion of applicants met pre-screening criteria?
Met criteria
~7 spots leftby Mar 2025