Safety and Efficacy of MCC-257 in the Treatment of Diabetic Polyneuropathy

• Nerve fiber density [ Time Frame: Day 1, Week 24 ]
• QST [ Time Frame: Day 1, Week 12, Week 24 ]
• Symptom [ Time Frame: Day 1, Week 12, Week 24 ]
• Clinical Global Impression [ Time Frame: Week 12, Week 24 ]

• Nerve fiber density
• QST
• Symptom
• Clinical Global Impression

The primary objectives of the study are to evaluate the efficacy and safety of three doses of MCC-257 in patients with mild to moderate diabetic polyneuropathy

The study will use a double-blind, randomized, placebo-controlled, fixed-dose, parallel-group design. Patients will be randomized equally to 1 of 4 treatment groups: MCC-257 20 mg, MCC-257 40 mg, MCC-257 80 mg, or placebo, given once daily for 24 weeks. The study will consist of 2 periods: 1) a screening period of up to 21 days prior to baseline, including a formal screening visit; and 2) a 24-week treatment period, during which patients will take the study treatment, and have various assessments performed during 4 visits.

• Drug: Placebo
  once daily for 24 weeks
• Drug: MCC-257
  20mg, once daily for 24 weeks
• Drug: MCC-257
  40mg, once daily for 24 weeks
• Drug: MCC-257
  80mg, once daily for 24 weeks

• Placebo Comparator: 1
  Intervention: Drug: Placebo
• Experimental: 2
  Intervention: Drug: MCC-257
• Experimental: 3
  Intervention: Drug: MCC-257
• Experimental: 4
  Intervention: Drug: MCC-257

Inclusion Criteria:

• The patient is male or female, 18-70 years of age
• The patient has either type 1 or type 2 diabetes
• The patient has mild to moderate diabetic neuropathy
• The patient is free from other clinically significant illness or disease, as determined by medical history, physical examination, laboratory evaluations, and other safety tests

Exclusion Criteria:

• Being treated with anticoagulants other than aspirin, such as warfarin, digoxin, Plavix
• BMI>40
• A significant disorder or a condition other than diabetes that can cause symptoms or physical conditions that mimic peripheral neuropathy or interfere with cognition
• Any proximal neuropathy, clinically evident nerve entrapment, or any focal trauma potentially affecting nerve function
• Women of childbearing potential who do not refrain from sexual activity or use adequate contraception
• Pregnant or lactating women
• An ALT or AST value >2X upper limit of normal (ULN)
• Clinically significant cardiovascular disease within the last six (6) months