Safety and Efficacy of AS-3201 in the Treatment of Diabetic Sensorimotor Polyneuropathy

Inclusion Criteria: * Patients with the following may enter: Clinical signs and symptoms (footpain, numbness, tingling, weakness, etc.) of symmetrical distal Diabetic Sensorimotor Polyneuropathy with diagnosis by Nerve Conduction Tests and/or Quantitative Sensory Test. * 18 to 70 years old of either sex and any race * Type I or Type II, insulin-dependent or non insulin-dependent diabetes for at least six months prior to study entry * Healthy in general * No hospitalizations for diabetic control or episodes of ketoacidosis for three months prior to screening * Female patients of childbearing potential must have a negative serum pregnancy test Exclusion Criteria: * Known non-diabetic causes of neuropathic symptoms * Diabetic patients with no neuropathy or severe neuropathy * Used any Aldose Reductase Inhibitors within one year of screening * Clinically significant illness including unstable cardiac, pulmonary, hematologic, hepatic, renal, or neoplastic disease * A history of systemic carcinoma within five years of screening * A history of epilepsy or serious head injury * A history or evidence of drug or alcohol abuse * Test positive at screening for hepatitis B surface antigen or hepatitis C antibody or have a history of a positive result, or patients with evidence of significant hepatic insufficiency * A history of known or suspected diagnosis of AIDS, or have tested seropositive for HIV antibody or antigen previously