Diabetic Neuropathy

Purpose of Study:  To evaluate the safety and effectivenessof 3 different doses of an investigational drug compared to placebo in Diabetics who have pain associated with peripheral neuropathy.

Inclusion Criteria:

• Age 18+
• Diagnosed with Type 1 or 2 Diabetes
• Painful diabetic peripheral neuropathy confirmed by neurological exam with symmetrical onset between 6 months and 10 years prior to screening
• HbA1c < 11% at screening

Exclusion Criteria:

• History of stroke or myocardial infarction within the past year
• Females who are pregnant, nursing or planning pregnancy
• Amputations that may affect the assessment of pain associated with DPN
• Renal transplant
• History of presence of psychiatric disorders (other than depression)
• History of clinically significant hypotension
• Presence of Hepatitis C virus or HIV at screening visit
• History of GI condition or gastric motility disorders that could affect drug absorption
• History of drug or alcohol abuse

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

• Study visits and study related procedures/tests
• Laboratory tests
• Study drug
• Reimbursement for time/travel expenses.

Inclusion/Exclusion Criteria Must Be Met