Taurine and painful diabetic neuropathy

INTERVENTION: Taurine 3,000 mg/day (3 capsules) orally vs placebo 3 capsules daily for 12 weeks CONDITION: Diabetic neuropathy ; Nervous System Diseases ; Diabetic neuropathy PRIMARY OUTCOME: 1. Pain perception is measured using the Short‐Form McGill‐Melzack Pain Questionnaire (SF‐MMPQ), a Visual Analogue Scale (VAS) and a Present Pain rating Intensity index (PPI) at baseline, 4, 8 and 12 weeks; 2. Pain is measured using daily pain diaries, recorded for 12 weeks. ; 3. Physician and Patient Global Assessment of Change, assessed at 12 weeks post inclusion into the study (final assessment) SECONDARY OUTCOME: 1. Sleep is measured using the Mean Sleep Interference Score on a daily basis upon awakening; 2. Mean Pain Scores are measured using daily diaries which comprise an 11‐point Likert‐type scale which ranges from 0 (no pain) to 10 (worst possible pain) upon awakening; 3. Change in the subjects overall status is measured using the Clinical and Patient Global Impression of Change at baseline, 4, 8 and 12 weeks INCLUSION CRITERIA: 1. Type 1 or type 2 diabetes as defined by the World Health Organization Classification 2. Duration of diabetes of at least 5 years 3. The HbA1c should be <10.5% with <1% fluctuation of HbA1c levels over the past 6 months 4. Age between 18 and 80 years 5. Women of childbearing potential must be using an acceptable method of contraception to prevent pregnancy when they are enrolled in the study and must agree to continue to practice an acceptable method of contraception for the duration of their participation in the study 6. Must meet the specified criteria for painful DN and have no risk factors for other causes for neuropathy 7. Willingness to sign the Center for Research Ethics Committee (COREC) approved informed consent form