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

Completed · Phase 2

Conditions studied: Peripheral Neuropathy, Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT01480297

Run by

University of Michigan

People needed

8

Starts

2011-11-01

Expected to finish

2014-09-01

Last updated by the study team

2015-04-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 1 diabetes (T1D)
• Peripheral neuropathy with symptoms of pain, or with other uncomfortable symptoms (e.g., burning, prickling).
• 18 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.
• Heart attack, heart bypass surgery, heart failure or a stroke EVER.
• Current treatment for any cancer (other than basal cell or squamous cell skin cancer).
• Treatment with lithium.
• Ever had Reyes' syndrome.
• Pregnant, nursing, or planning to become pregnant during the time of the study.
• Allergic to lidocaine or epinephrine (used for numbing skin prior to biopsies).
• Keloid scarring in the past.
• Receiving other experimental treatments.

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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