An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain

An Open-Label, Randomized Comparison of Duloxetine, Pregabalin, and the Combination of Duloxetine and Gabapentin Among Patients With Inadequate Response to Gabapentin for the Management of Diabetic Peripheral Neuropathic Pain

To test the non-inferiority of duloxetine monotherapy as a treatment for the management of diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who have not had an adequate response to gabapentin.

Inclusion Criteria:

• You must have been diagnosed with Diabetic Neuropathic Pain
• Patient has an average daily pain score greater than or equal to 4 on an 11-point Likert scale, and patient or provider feel that a change from the current gabapentin therapy for pain management is warranted
• Patient is currently treated with gabapentin greater than or equal to 900 milligram/day, has been prescribed the current dose for at least 4 weeks, and has been at least 80% compliant with dosing, according to patient report
• Patient must agree not to change dose of gabapentin between Visits 1 and 2
• You must have stable glycemic control

Exclusion Criteria:

• Are judged prior to randomization to be at suicidal risk as defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II)
• Current diagnosis or history of hemangiosarcoma
• Patients with New York Heart Association Class III or IV symptoms of congestive heart failure
• Patients with uncontrolled narrow-angle glaucoma
• Presence of a current seizure disorder