randomized, double-blind study to assess the efficacy and safety of α-lipoic acid versus bk-c-0701 in subjects with diabetic neuropathy

Conditions: Diabetic Neuropathies

Summary: the purpose of this study is to determine the: primary end point * change of total symptom score secondary end point * neurological test

total symptom score shall be calculated from the data of burning, numbness, stabbing pain, paraesthesiae.

Eligibility criteria:
inclusion criteria: * diabetes mellitus (type i or ii), as defined by the american diabetes association, 1997, lasting 1 year and is well-controlled. * patient with symmetric sensory-motor diabetic neuropathy which is above stage 2 * result of pin-prick test is 'absent' or 'reduced' * hba1c \<10% * total symptom score ≥ 4 points * at least 1 of the 4 symptoms of the tss must have occurred continuously over the last 3 months. * patient over 19 years of age * female who is postmenopausal or is willing to use an effective method of contraception during the study (effective method=iud, spermicide with condom, abstinence) or is surgically sterile (underwent a total hysterectomy or bilateral tubal ligation). exclusion criteria: * patient who has proximal asymmetric neuropathy, cranial neuropathies, truncal radiculopathy, diabetic plexopathies, acute or active mononeuropathies (cranial neuropathies, post-herpes neuralgias) * patient who has neuropathy from alcohol, drug (cisplatin, taxol , etcs), malignant cancer or has a medical history of nerve system disease such as parkinson's disease/ epilepsy/ multiple sclerosis, etcs. * patient who has nerve system disease which can cause sensory loss myopathy of any cause. * peripheral vascular disease severe enough to cause ischemic ulcers or limb ischemia. * patients with diabetic proliferating retinopathy requiring immediately therapy and impending blindness. * patients with any active neoplastic disease except benign tumor or nonrecurrent malignant tumor for 5 years. * patients with clinically significant cardiac, pulmonary, gastrointestinal, haematological, or endocrine disease that may confound interpretation of the study results or prevent the patient from completing the study. * patients with atrial fibrillation. * patients who have had organ transplants of any kind. * patients with significant hepatic or renal disease (ast, alt or ggt \>2 times normal, serum creatinine \>1.8 mg/dl (\>159 mmol/l) for males or \>1.6 mg/dl (\>141 mmol/l) for females). * patients with a recent history (within last 12 months) of drug or alcohol abuse. * use of any investigational drug (participation in a clinical trial) within last 1 month. * history of severe or anaphylactic reaction to drugs, sulfur or biologic products. * recent (within last 3 months) ketoacidosis or hypoglycaemia, necessitating hospital admission. * existing foot ulcers. * pregnant or lactating females * history of allergic reaction to the study medication or its excipients. * psychiatric, psychological, or behavioural symptoms that would interfere with the patient's ability to participate in the trial. * patient who is not suitable to trial by investigator judgment. * patient who does not write informed consent prior to start of trial and cannot comply with the trial requirements. * antioxidant therapy (vitamins e \> 400 iu, c \> 200 mg, and beta-carotene \> 30 mg) or pentoxyphylline within last 1 month before start of trial. * use of thioctic acid (\> 50 mg), evening primrose oil or any other gamma-linolenic acid containing substance within the last 3 months. * use of analgesic within \>5times of a half-life before administration of investigational medication. * use of anticonvulsants(include pregabalin), antidepressants within 4 weeks before administration of investigational medication.