Diabetic Peripheral Neuropathy
Conditions
Brief summary
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.
Interventions
DRUGPregabalin 150mg + Alpha-lipoic acid 480mg
Pregabalin qd + alpha-lipoic acid qd
DRUGPregabalin 150mg
pregabalin qd
DRUGAlpha-Lipoic Acid 480mg
alpha-lipoic acid qd
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual analogue scale (VAS) | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| visual analogue scale (VAS) | 6 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 |
| total symptom score, TSS | 6 weeks, 12 weeks |
Countries
South Korea
Outcome results
None listed