Safety and Efficacy of AEG33773 Versus Placebo in Patients With Painful Diabetic Peripheral Neuropathy

Inclusion Criteria: * Male or female age 18 to 75 years * Patients with type 1 or type 2 diabetes mellitus * DPN as determined by the investigator based on clinical history, clinical examination, and assessment of signs and symptoms * Stable diabetic control over the preceding 3 months, as determined by the investigator based on available medical information (e.g., hemoglobin A1c \[HbA1c\] and/or blood glucose levels) * HbA1c ≤ 12 % at the Screening visit * Pain persisting for more than 3 months and less than 5 years * Completion of 3 daily pain intensity reports (using the 11-point NPRS) over the 3 days immediately preceding the day of randomization * Pain intensity (NPRS) score of ≥ 5 for all 3 of the 3 days immediately preceding the day of randomization * Completed a washout (before first NPRS assessment) of at least 7 days for any of the following medications: α2-δ antagonists (e.g., gabapentin, pregabalin), opiate analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), topical lidocaine, anti-epileptic drugs, serotonin and norepinephrine reuptake inhibitors (SNRIs) (e.g., duloxetine), tricyclic antidepressants prescribed for pain, skeletal muscle relaxants, orally administered steroids, capsaicin, mexiletene, centrally acting analgesics (dextromethorphan, tramadol), alpha lipoic acid, and any supplement or herbal product used to treat DPN symptoms * Women must be neither pregnant nor lactating. Women of childbearing age must have a confirmed negative pregnancy test and must practice medically acceptable methods of contraception throughout the trial and for at least 30 days after the last dose of study drug * Male subjects and/or their female partners must be using medically acceptable methods of contraception for the entire duration of the study, and for at least 90 days after the last study drug dose * Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study * A willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures Exclusion Criteria: * Age younger than 18 years or older than 75 years * Are pregnant or breast feeding * Female patients of childbearing potential unwilling to use a medically acceptable form of contraception (i.e., hormonal birth control, intrauterine device \[IUD\], double barrier \[male condom or female condom with a diaphragm\], or a barrier method plus a spermicidal agent \…