Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Inclusion criteria

• . Age \> 18 years of age
• . Able to give informed consent and willing to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
• . Type 1 or type 2 diabetes with a hemoglobin A1c (HbA1c) ≤ 10% at Screening and on a stable antidiabetic medication regimen for at least 30 days prior to Screening (insulin therapy is acceptable)
• . Painful distal symmetrical sensorimotor polyneuropathy (as per American Society of Pain Educators guidelines ) diagnosed for at least 6 months, based on neurological history and/or examination; diagnosis includes absent or reduced deep tendon reflexes at both ankles
• . At Screening, a pain score of ≥ 40 mm on the SF-MPQ VAS
• . At Randomization, a pain score of ≥ 40 mm on the SF-MPQ VAS and an ADPS of ≥ 4 on the 11-point NRS, the latter calculated from a minimum of 4 pain ratings in daily diaries obtained during the 1-week Baseline Period (prior to randomization)
• . Creatinine clearance \> 60 mL/min (estimated using the Cockcroft-Gault equation)
• . Antidiabetic and other medications anticipated to remain stable and constant during the study period

Exclusion criteria