Randomized, Double-blind Study to Assess the Efficacy and Safety of α-lipoic Acid Versus BK-C-0701 in Subjects With Diabetic Neuropathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the: Primary end point change of Total symptom score Secondary end point neurological test

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

Official Title
-----------------
Phase III 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

Intervention / Treatment
-----------------
* Drug: BK-C-0701


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BK-C-0701, diabetic neuropathy<br> | Drug: BK-C-0701<br>* tablet, 8 weeks<br>|
| Active Comparator: alpha lipoic acid, diabetic neuropathy, capsule<br> | Drug: BK-C-0701<br>* tablet, 8 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TSS |  | 8 weeks |