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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Treatments: Salicylsalicylic acid; Sodium Salicylate

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.