A Study for Treatment of Pain in Patients With Diabetic Neuropathy.

Exclusion Criteria

• •Have historical exposure to drugs known to cause neuropathy, or a history of a medical condition, including pernicious anemia and hypothyroidism, that could have been responsible for neuropathy.
• •Have pain that cannot be clearly differentiated from or conditions that interfere with the assessment of diabetic neuropathy pain.
• •Have had treatment with any centrally active neuroleptic drug within 30 days of visit 3.
• •Have had intolerance to pregabalin or have frequent and/or severe allergic reactions with multiple medications.
• •Have current or previous (within the past 1 year) Axis 1 diagnosis of major depressive disorder, mania, bipolar disorder, psychosis, dysthymia, generalized anxiety disorder, alcohol or eating disorders according to Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria, as determined by the investigator and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
• •Have a serious of unstable cardiovascular, hepatic, renal, respiratory, ophthalmologic, gastrointestinal, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition that in the opinion of the investigator would compromise participation or be likely to lead to hospitalization during the course of the study.
• •Have alanine aminotransaminase \> 2 times upper limit of normal at Visit 1, based on reference ranges of central lab.
• •Have prior renal transplant, current renal dialysis, or serum creatinine laboratory values \> 1.5 times upper limit of normal, based on reference ranges of the central lab at Visit 1.
• •Have a diagnosis or history of glaucoma.
• •Are taking excluded medication that cannot be stopped and washed out prior to Visit 2.
• •Have history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
• •Are judged clinically by the investigator to be at suicidal risk in the opinion of the investigator based upon clinical interview and the Columbia Suicide-Severity Rating Scale.
• •Have a positive urine drug screen for any substance of abuse or excluded medication.
• •Are unwilling or unable to comply with the use of a data collection device to directly record data from the subject (daily diary).
• •Are pregnant or breast-feeding.
• •Are investigator site personnel directly affiliated with this study and/or their immediate families.
• •Are Lilly employees.
• •Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
• •Have a history of recurrent seizures other than febrile seizures.
• •Have a history of severe gastroparesis.