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

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

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

Indications