This study will evaluate the efficacy and safety of low-dose duloxetine combined with alpha-lipoic acid compared with standard-dose duloxetine in adults with painful diabetic peripheral neuropathy. In this assessor-blinded, randomized, parallel-arm, non-inferiority trial, participants will be assigned in a 1:1 ratio to receive either duloxetine 30 mg once daily plus alpha-lipoic acid 600 mg once daily or duloxetine 60 mg once daily. The primary outcome will be the change in pain intensity measured by the Numerical Rating Scale from baseline to Week 9. Secondary outcomes will include changes in pain intensity at Week 5, Patient Global Impression of Change at Weeks 5 and 9, the proportion of participants achieving at least a 30% reduction in pain intensity, adverse effects, treatment tolerability and treatment compliance.
Age ≥18 years.
Diagnosed case of diabetes mellitus.
Diabetic peripheral neuropathy diagnosed clinically according to the Toronto Clinical Neuropathy Score (TCNS) criteria with a TCNS score ≥6, with painful neuropathy confirmed using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale with a score ≥12.
Duration of neuropathic symptoms ≥3 months.
Pain attributable to causes other than diabetic peripheral neuropathy, such as peripheral arterial disease (ischaemic pain), osteoarthritis, inflammatory arthritis, phantom limb pain, radiculopathy, or other chronic pain disorders.
Known vitamin B12 deficiency, hypothyroidism, chronic alcohol use, hereditary neuropathy, chemotherapy-induced neuropathy, HIV infection, or connective tissue disease.
Chronic kidney disease (CKD) stage ≥4.
Chronic liver disease or significant hepatic impairment (ALT >3 times the upper normal limit).
Parallel
Duloxetine
DrugDuloxetine will be administered orally once daily. During Week 1, all participants will receive duloxetine 30 mg once daily. From Week 2 onward, participants in the low-dose combination group will continue duloxetine 30 mg once daily in combination with alpha-lipoic acid 600 mg once daily, whereas participants in the standard-dose duloxetine group will receive duloxetine 60 mg once daily. Treatment will continue through Week 9.
Alpha-Lipoic Acid
DrugAlpha-lipoic acid 600 mg will be administered orally once daily in combination with duloxetine 30 mg once daily to participants assigned to the low-dose combination group. Treatment will be administered from Week 2 through Week 9.
Change in pain intensity measured by Numerical Rating Scale (NRS) from baseline to Week 9
Change in pain intensity from baseline to Week 9, measured using the Numerical Rating Scale (NRS), a 0-10 scale in which 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate worse pain and therefore a worse outcome.
Change in pain intensity measured by Numerical Rating Scale (NRS) from baseline to Week 5
Change in pain intensity from baseline to Week 5, measured using the Numerical Rating Scale (NRS), a 0-10 scale in which 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate worse pain and therefore a worse outcome.
Patient Global Impression of Change (PGIC)
Patient-reported global assessment of change in painful diabetic peripheral neuropathy symptoms using the Patient Global Impression of Change (PGIC), a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), with 4 indicating no change. Lower scores indicate greater improvement and therefore a better outcome.
Proportion of participants achieving ≥30% reduction in pain intensity
Proportion of participants achieving a ≥30% reduction in pain intensity from baseline to Week 9, measured using the Numerical Rating Scale (NRS), a 0-10 scale in which 0 indicates no pain and 10 indicates the worst possible pain. A reduction in NRS score indicates improvement.
Incidence, type, frequency, and severity of treatment-emergent adverse events
Type, frequency, and severity of adverse events occurring during the study period. Adverse events will be assessed and recorded from baseline through Week 9, including events leading to treatment discontinuation.
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