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

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhan Corporation
• Treatments: Pregabalin; Thioctic Acid

Criteria

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