Diabetic Neuropathy

Drug under Investigation: Undisclosed

Purpose of Study:  To assess the efficacy and safety of three fixed dosage levels of study medication in subjects with painful distal diabetic neuropathy.

Inclusion Criteria:

• Age 18 years or older
• Diagnosed with diabetes mellitus (Type I or Type II)
• Have symptoms of painful distal diabetic neuropathy for 6 months to 5 years
• Have HbA_1c levels <12% with optimized diabetic control for at least 3 months prior to enrollment

Exclusion Criteria:

• Current or recent (within the last 30 days) participation in another trial of an investigational drug or medical device
• Have other conditions that cause chronic pain at least as severe as the diabetic neuropathy pain
• May not take these medications during the trial, or for 7 days before enrolling: AEDs, muscle relaxants, mexiletine, analgesics, opioids
• Have had an amputation related to diabetes, other than toe amputations
• Have major skin ulcers
• Have impaired renal function
• Have experienced myocardial infarction within the last 12 months
• Have a history of alcohol or drug abuse within the last year

If you qualify, all study related care is provided at no charge including:

• Study visits and study related procedures/tests
• Laboratory tests
• Financial compensation for time/travel expenses

Inclusion/Exclusion Criteria Must Be Met