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

Phase 4 Completed 151 enrolled Yuhan Corporation

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2021-05-14
Primary completion: 2022-11-30
Completion: 2022-11-30

Outcome

Met primary endpoint

paper The pregabalin monotherapy demonstrated non-inferiority compared to the combination therapy in alleviating DPN pain. PMID 42056717 ↗

Publications

Oh TJ, Kim SS, Lee SH, Kwon HS, Kim ES, Rhee EJ, Yoo HJ, Jang HN, Lee WJ, Kim ES, Kim SY, Koh G, Hong EG, Park TS, Won JC. Efficacy and Safety of Pregabalin and Alpha-Lipoic Acid Combination in Patients With Painful Diabetic Peripheral Neuropathy: A Randomized, Open-Label, Non-Inferiority, Phase IV Clinical Trial and Subgroup Analysis (OPTIMUM Study). Diabetes Obes Metab. 2026 Jul;28(7):6172-6183. doi: 10.1111/dom.70795. Epub 2026 Apr 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pregabalin	Small molecule	150 mg	—
Subject	alpha-lipoic acid	Small molecule	480 mg	—