Pregabalin and Alpha-lipoic Acid Combination Versus Each Monotherapy in Patients With Diabetic Peripheral Neuropathy

Study Overview
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Brief Summary
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This study is a randomized, parallel, open-label, multicenter, phase IV clinical trial to assess the efficacy and safety of pregabalin and alpha-lipoic acid combination compared with each monotherapy in patients with diabetic peripheral neuropathy for 12 weeks.

Official Title
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Efficacy and Safety of Pregabalin and Alpha-lipoic Acid Combination Versus Each Monotherapy in Patients With Diabetic Peripheral Neuropathy: a Randomized, Parallel, Open-label, Multicenter, Phase IV Clinical Trial (OPTIMUM Trial)

Conditions
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Diabetic Peripheral Neuropathy

Intervention / Treatment
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* Drug: Pregabalin 150mg + Alpha-lipoic acid 480mg
* Drug: Pregabalin 150mg
* Drug: Alpha-Lipoic Acid 480mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 19 to 75 type 2 diabetes mellitus with HbA1c (Hemoglobin A1c) ≤ 10 % peripheral (eg. hands, feet) neuropathic pain (eg. abnormal sensations, numbness, pain, etc.) within 3 months (12 weeks) diagnosed with diabetic peripheral neuropathy (DPN) VAS pain score ≥ 40 mm written informed consent Exclusion Criteria: brittle diabetes mellitus ALT (Alanine Transaminase), AST (Aspartate Transaminase), CPK (Creatine Phosphokinase) level ≥ 3 times the upper limit of normal (UNL) or active liver disease severe renal impairment (eGFR (estimated glomerular filtration rate) < 60 mL/min/ 1.73m2) treated with antiepileptic drugs within 1 week at randomization other nervous system or neuropathic disorders that may affect pain evaluation oral drug administration is not possible, or hypersensitive or allergic to pregabalin, r-thioctic acid tromethamine, thioctic acid, and other excipients pregnant, lactating, or childbearing potential alcoholics, drug abusers, and patients who are difficult to participate in clinical trials due to psychological and emotional problems have participated in other clinical trials within 30 days at screening

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregabalin and alpha-lipoic acid combination therapy<br>Alpha-lipoic acid 480 mg/tablet once daily before breakfast and Pregabalin 150 mg/tablet once daily before bedtime will be administrated for 12 weeks. | Drug: Pregabalin 150mg + Alpha-lipoic acid 480mg<br>* Pregabalin qd + alpha-lipoic acid qd<br>|
| Experimental: Pregabalin monotherapy<br>Pregabalin 150 mg/tablet once daily before bedtime will be administrated for 12 weeks. | Drug: Pregabalin 150mg<br>* pregabalin qd<br>|
| Active Comparator: Alpha-lipoic acid monotherapy<br>Alpha-lipoic acid 480 mg/tablet once daily before breakfast will be administrated for 12 weeks. | Drug: Alpha-Lipoic Acid 480mg<br>* alpha-lipoic acid qd<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue scale (VAS) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue scale (VAS) |  | 6 weeks | 
| visual analogue scale (VAS) reduction rate of more than 30% |  | 6 weeks, 12 weeks | 
| visual analogue scale (VAS) reduction rate of more than 50% |  | 6 weeks, 12 weeks | 
| brief pain inventory Korean version, BPI-K |  | 6 weeks, 12 weeks | 
| total symptom score, TSS |  | 6 weeks, 12 weeks | 
| pain detect questionnaire, PD-Q |  | 6 weeks, 12 weeks | 
| 3 level version of Euro-Qol-5 dimensions, EQ-5D-3L |  | 6 weeks, 12 weeks |