Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

Exclusion Criteria

• •The subject has failed previous treatment with duloxetine for DNP.
• •Subject has a diagnosis of narrow-angle glaucoma.
• •Subject has a history of an allergic reaction or intolerance to duloxetine, acetaminophen, or any other NNR agonist.
• •Subject has a diagnosis of fibromyalgia that requires treatment.
• •Subject has a functioning implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
• •Subject has a history of seizures (febrile may be ok) or major depressive episode within the past two (2) years or major psychiatric disorder including bipolar disorder, schizophrenia or borderline personality disorder.
• •Subject has a history of myocardial infarction (MI) within six (6) months of the Screening Visit.
• •Subject has unstable angina.
• •Subject has ventricular arrhythmia requiring anti-arrhythmic therapy.
• •Subject has undergone a cardiac revascularization procedure within 30 days of Screening.
• •Subject has uncontrolled hypertension (HTN) defined as a systolic blood pressure (BP) \>= 160 and/or a diastolic blood pressure (BP) \>= 100 at Screening and/or Baseline.
• •Subject has a clinically significant abnormal ECG at Screening
• •Subject has an active malignancy of any type or has been diagnosed with or treated for cancer within the past 5 years.
• •Subject has a positive result for drugs of abuse at Screening with the exception of a positive result for a known prescribed medication.
• •Subject's screening laboratory results show hepatitis A, B or C.
• •Subject has a known or suspected history of Human Immunodeficiency Virus (HIV).