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