Pilot Study to Determine Effects of Salsalate in Type 1 Diabetes and Painful Peripheral Neuropathy

NCT01480297 | Completed Phase 2 Results

• 1 other identifier: SALP
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This 12 week study will examine the effects of daily Salsalate treatment on markers of neuropathic pain and intra-epidermal nerve fiber density. the study is being done in people with type 1 diabetes with signs and symptoms of peripheral neuropathy.

Conditions

Peripheral Neuropathy; Type 1 Diabetes

Keywords

Pain; Neuropathy; Diabetes type 1

Outcome Measures

Primary Outcomes (1)

• Intra-epidermal Nerve Fiber Density (IENFD) Fibers Per mm

  Intra-epidermal Nerve Fiber Density (IENFD) was measured at two anatomic locations (thigh and ankle) at baseline and after 12 weeks of treatment with Salsalate. IENFD is expressed as fibers per mm. Means and standard deviations are shown.

  Baseline and 12 weeks

Study Arms (1)

Salsalate

EXPERIMENTAL

All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).

Drug: Salsalate

Interventions

Salsalate DRUG

Salsalate 3 grams daily (1 gram TID with meals)

Also known as: Salsalate (Amneal Pharmaceuticals)

Salsalate

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 diabetes (T1D)
• Peripheral neuropathy with symptoms of pain, or with other uncomfortable symptoms (e.g., burning, prickling).
• to 70 years old
• Stable insulin treatment program for at least the past 3 months.
• Abnormal nerve conduction studies (based on study screening examination)
• Willing and able to take an oral (by mouth) medication 3 times per day for 3 months.
• WOMEN using an appropriate method of contraception during the course of the study (hormonal, IUD, or diaphragm.
• Willing and able to provide written informed consent for study participation.

You may not qualify if:

• Neuropathy from a cause other than diabetes.
• Allergy to salsalate or similar medications (aspirin, non-steroidal anti-inflammatory medicines like ibuprofen and naproxen).
• Currently on blood thinning agents such as Coumadin, Heparin, Plavix, Pradaxa, high-dose aspirin (more than 325 mg daily).
• Any severe low blood sugar episodes in the past 6 months (needed assistance to treat).
• Diabetic ketoacidosis in the past 6 months.
• Severe neuropathy, or have had an ulcer or amputation on either foot or either leg.
• Creatinine level (a measure of kidney function is greater than 1.4 mg/dl (for women) or greater than 1.5 mg/dl (for men) or your estimated GFR is under 60.
• Albumin in your urine or other signs of reduced kidney function.
• Liver enzymes (including ALT, AST and Bilirubin) levels are more than 2 and ½ times the upper limit of normal.
• Blood platelets are less than 100,000 at the time of screening.
• Organ transplant (lung, kidney, heart, pancreas, liver).
• Chronic immunosuppressive therapy, for example, daily prednisone or other steroids, methotrexate, Imuran, CellCept. This includes daily, or recurrent use of oral steroids used to treat asthma.
• Regular NSAID medications (e.g., Naproxen, Ibuprofen) use. If used occasionally, you will be asked to not use them during the study.
• History of drug or alcohol abuse, or if you take more than 10 alcoholic drinks per week.
• History of stomach ulcers or bleeding from your bowel.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Diabetes Mellitus, Type 1; Pain

Interventions

salicylsalicylic acid

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Rodica Pop-Busui, MD, PhD
• Organization: The University of Michigan

rpbusui@umich.edu

734-763-3056

Study Officials

• Rodica Pop-Busui, MD, PhD

  University of Michigan, Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: November 23, 2011
• First Posted: November 28, 2011
• Study Start: November 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: September 1, 2014
• Last Updated: April 24, 2015
• Results First Posted: April 24, 2015

Record last verified: 2015-04

Locations

US (1)