Benfotiamine Versus Vitamin B1-6-12 for Diabetic Peripheral Neuropathy

Summary

The purpose of this clinical trial is to compare the efficacy of benfotiamine with vitamin B1-6-12 in reducing sensory neuropathy symptoms, numbness and pain in patients with diabetic peripheral neuropathy. The main questions this study aims to answer are: * Does benfotiamine reduce overall sensory neuropathy symptoms more effectively than vitamin B1-6-12? * Does benfotiamine reduce numbness more effectively than vitamin B1-6-12? * Does benfotiamine reduce pain more effectively than vitamin B1-6-12? Researchers will compare benfotiamine with vitamin B1-6-12 in a double-blind study. Both treatments will be manufactured as visually identical study medications to maintain blinding. The study will evaluate whether benfotiamine provides greater improvement in sensory neuropathy symptoms, numbness, and pain than vitamin B1-6-12 in patients with diabetic peripheral neuropathy. Participants will: * undergo screening for vitamin B12 deficiency before enrollment. Patients with vitamin B12 deficiency will not be eligible for participation. * randomly assigned to receive either benfotiamine or vitamin B1-6-12, taken orally twice daily for 3 months. * attend two on-site clinic visits (baseline and the end of the study) and complete two telephone follow-up assessments during the study. * continue their usual medications throughout the study, provided that no new neuropathic pain medications are initiated and the dose of existing neuropathic pain medications remains unchanged.

Timeline

Start

2026-07-15

Primary completion

2027-06-30

Completion

2027-06-30

Publications

• Background Management of peripheral neuropathy symptoms with a fixed dose combination of high-dose vitamin B1, B6 and B12: A 12-week prospective non-interventional study in Indonesia. (2018). Asian Journal of Medical Sciences, 9(1), 32-40. https://doi.org/10.3126/ajms.v9i1.18510
• Background The Role of Vitamins B Complex in the Management of Diabetic Peripheral Neuropathy: an Electrophysiological Study. (2024). The Review of Diabetic Studies , 19(3). https://diabeticstudies.org/index.php/RDS/article/view/370
• Background Sathienluckana T, Palapinyo S, Yotsombut K, Wanothayaroj E, Sithinamsuwan P, Suksomboon N. Expert consensus guidelines for community pharmacists in the management of diabetic peripheral neuropathy with a combination of neurotropic B vitamins. J Pharm Policy Pract. 2024 Feb 7;17(1):2306866. doi: 10.1080/20523211.2024.2306866. eCollection 2024.
• Background Gerould H, Mangrum R, Robinson RL, Schantz K, Bryant A, Delbecque L, Behrend B, Price KL, Stauffer VL, Secinti E. Evaluating the Content Validity of the Modified Neuropathy Total Symptom Score-6 Self-Administered (mNTSS-6-SA) in a Painful Diabetic Peripheral Neuropathy Population. J Pain Res. 2025 Nov 12;18:6045-6055. doi: 10.2147/JPR.S539056. eCollection 2025.
• Background Bastyr EJ 3rd, Price KL, Bril V; MBBQ Study Group. Development and validity testing of the neuropathy total symptom score-6: questionnaire for the study of sensory symptoms of diabetic peripheral neuropathy. Clin Ther. 2005 Aug;27(8):1278-94. doi: 10.1016/j.clinthera.2005.08.002.
• Background Ziegler D, Tesfaye S, Spallone V, Gurieva I, Al Kaabi J, Mankovsky B, Martinka E, Radulian G, Nguyen KT, Stirban AO, Tankova T, Varkonyi T, Freeman R, Kempler P, Boulton AJ. Screening, diagnosis and management of diabetic sensorimotor polyneuropathy in clinical practice: International expert consensus recommendations. Diabetes Res Clin Pract. 2022 Apr;186:109063. doi: 10.1016/j.diabres.2021.109063. Epub 2021 Sep 20.
• Background Balakumar P, Rohilla A, Krishan P, Solairaj P, Thangathirupathi A. The multifaceted therapeutic potential of benfotiamine. Pharmacol Res. 2010 Jun;61(6):482-8. doi: 10.1016/j.phrs.2010.02.008. Epub 2010 Feb 25.
• Background Bozic I, Lavrnja I. Thiamine and benfotiamine: Focus on their therapeutic potential. Heliyon. 2023 Nov 7;9(11):e21839. doi: 10.1016/j.heliyon.2023.e21839. eCollection 2023 Nov.
• Background Fraser DA, Diep LM, Hovden IA, Nilsen KB, Sveen KA, Seljeflot I, Hanssen KF. The effects of long-term oral benfotiamine supplementation on peripheral nerve function and inflammatory markers in patients with type 1 diabetes: a 24-month, double-blind, randomized, placebo-controlled trial. Diabetes Care. 2012 May;35(5):1095-7. doi: 10.2337/dc11-1895. Epub 2012 Mar 23.
• Background Haupt E, Ledermann H, Kopcke W. Benfotiamine in the treatment of diabetic polyneuropathy--a three-week randomized, controlled pilot study (BEDIP study). Int J Clin Pharmacol Ther. 2005 Feb;43(2):71-7. doi: 10.5414/cpp43071.
• Background Stracke H, Gaus W, Achenbach U, Federlin K, Bretzel RG. Benfotiamine in diabetic polyneuropathy (BENDIP): results of a randomised, double blind, placebo-controlled clinical study. Exp Clin Endocrinol Diabetes. 2008 Nov;116(10):600-5. doi: 10.1055/s-2008-1065351. Epub 2008 May 13.

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Indications