Study of DA-9801 to Treat Diabetic Neuropathy

Inclusion Criteria

• Must be 18 to 75 years of age
• Diagnosed with Type I or Type II diabetes
• HbA1c ≤ 12% at the time of screening
• Has diabetic neuropathic pain (numbness, soreness, shooting or poking pain) in the lower extremities for more than 3 months prior to screening and with no adequate relief from other treatments
• Has an average pain score of ≥ 4 for 24 hours at least 4 days out of the week prior to randomization as assessed by the 11-point Likert NRS.
• If female of childbearing potential, subject must have a negative serum pregnancy test at screening
• Understands and is willing to participate in the clinical study and can comply with study procedures and visits.
• Normal cognitive and communicative ability as judged by clinical assessment and ability to complete self-reported questionnaires
• Subject is willing and able to give informed consent

Exclusion Criteria

• Evidence of another type of neuropathic pain caused by a condition other than diabetes
• Pain from another source as severe or greater than the pain under study
• BMI (Body Mass Index) > 37 kg/m2
• Clinical signs of infection related to sores of any type on the legs
• Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening; or subject or physician anticipates use of any of these therapies by the subject during the course of the study
• Previous participation in the Treatment Phase of this Protocol
• History of drug or alcohol abuse, within the past 6 months
• Malignant disease not in remission for 5 years or more that has been medically or surgically treated without evidence of metastases
• Presence of one or more medical conditions, as determined by medical history, which seriously compromises the subject's ability to complete the study, including history of poor adherence with medical treatment, renal, hepatic, hematologic, active auto-immune or immune diseases that, in the opinion of the Investigator, would make the subject an inappropriate candidate for this study: c) One or more abnormal blood biochemistry analyte result that is ≥ 3 times that of the upper limit of the normal range; d) For laboratory results that are significantly lower than the normal range, specific criteria will be used to judge subject eligibility for randomization for Total protein, Albumin, and Hemoglobin or Platelets.
• Known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history known to be infected with Human Immunodeficiency Virus (HIV)
• New York Heart Association (NYHA) Class III and IV congestive heart failure (CHF), as defined by the following criteria: a)Class III: Symptoms with moderate exertion b)Class IV: Symptoms at rest
• Pregnant or breast feeding
• Women of child-bearing potential not using an effective birth control method. Women of child-bearing potential are defined as women physiologically capable of becoming pregnant, UNLESS they meet the following criteria:

d) Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40mIU/m, OR; e) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy, OR; f) Are using one or more of the following acceptable methods of contraception: surgical sterilization, hormonal contraception, and double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 days after study discontinuation.

• Subjects with a diagnosis of psychiatric disorders such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, generalized anxiety, dysthymia or suicidality/suicide ideation
• Administration of local anesthetic shot or systemic steroids within two months of screening
• Subjects not willing to undergo a two-week washout period for pharmacologic and non-pharmacologic pain management techniques