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

NCT07708233 | Recruiting Phase 4

• 1 other identifier: 68PH174
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Peripheral Neuropathy (DPN)

Keywords

benfotiamine; Vitamin B; Daibetic neuropathy; diabetic peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• Mean change NTSS-6

  Neuropathy Total Symptom Score-6 (NTSS-6) is a score measured severity and frequency of 6 sensory neuropathy symptoms that common in diabetic peripheral neuropathy (numbness, Aching pain, Burning pain, Allodynia, Prickling sensation, Lancinating pain) Maximum score 21.96 Minimum score 0 which higher score represent more severity of sensory neuropathy symptoms. Minimally clinically important differences (MCIDs) is different between group 1.26 points.

  From enrollment to 4, 8 and 12 weeks of treatment.

Secondary Outcomes (3)

• Mean change of numbness score

  From enrollment to the end of treatment at 12 weeks

• Mean change numerical rating scale for pain

  From enrollment to 4, 8 and 12 weeks of treatment at

• The proportion (%) of participants who achieved a Patient Global Impression of Change (PGIC) score of 1-2

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Benfotiamine

EXPERIMENTAL

Parcipitant in this arm will recieve benfotiamine 300 mg per day

Drug: Benfotiamine

Vitamin B 1-6-12

ACTIVE COMPARATOR

Parcipitant in this arm will recieve Vitamin B1-6-12 combined pill (total B1 200 mg, B6 10 mg and B12 130 mcg per day)

Drug: Vitamin B1-6-12

Interventions

Benfotiamine DRUG

Benfotiamine arm - participants receive benfotiamine 150 mg orally twice daily for 3 months. Benfotiamine is provided as blinded study medication that is visually identical to the comparator to maintain double blinding.

Benfotiamine

Vitamin B1-6-12 DRUG

Vitamin B1-6-12 arm- participants receive vitamin B1-6-12 (B1 100 mg, B6 5 mg, B12 65 mcg per tablet) orally twice daily for 3 months. The study medication is manufactured to be visually identical to benfotiamine to maintain double blinding.

Vitamin B 1-6-12

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Diagnosis of diabetic peripheral neuropathy confirmed by a physician based on the following ICD-10 codes: E11.42: Type 2 diabetes mellitus with diabetic polyneuropathy; or E11: Type 2 diabetes mellitus, combined with either:
• M79.2: Neuralgia and neuritis, unspecified; or G62.9: Polyneuropathy, unspecified.
• Presence of sensory neuropathy symptoms assessed using the Neuropathy Total Symptom Score-6 (NTSS-6), with: Total NTSS-6 score ≥1; and Numbness symptom score (NTSS-6 item 6) ≥1.
• No evidence of vitamin B12 deficiency, defined as a serum vitamin B12 level ≥200 pg/mL (148 pmol/L).
• provide informed consent and participate in the study.

You may not qualify if:

• Presence of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltose malabsorption.
• Adjustment of doses of medications used for neuropathic pain control within 6 weeks prior to study enrollment, including tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), gabapentinoids, or other neuropathic pain medications.
• Presence of other conditions that may affect diabetic peripheral neuropathy or neuropathic pain, including:
• Chemotherapy-induced peripheral neuropathy due to neurotoxic agents within 6 months prior to enrollment, including vinca alkaloids, taxanes, platinum-based agents, proteasome inhibitors, thalidomide, brentuximab vedotin, or ado-trastuzumab emtansine.
• HIV/AIDS with any of the following: Current or previous treatment with didanosine, stavudine, or zalcitabine; CD4 count \<200 cells/mm³; or HIV viral load \>1,000 copies/mL.
• Drug-induced polyneuropathy (ICD-10: G62.0).
• Polyneuropathy due to other toxic agents (ICD-10: G62.2).
• Alcoholic polyneuropathy (ICD-10: G62.1).
• Fibromyalgia (ICD-10: M79.7).
• Planned surgery within 3 months prior to or during the study period.
• Previous pain-relief procedures, including:
• Transcutaneous electrical nerve stimulation (TENS) or temporary peripheral nerve stimulation (PNS) within 1 year prior to enrollment;
• Permanent PNS;
• Pulsed radiofrequency or radiofrequency ablation within 6 months prior to enrollment;
• Botulinum toxin injection for neuropathic pain relief within 12 weeks prior to enrollment.

Sponsors & Collaborators

• Thammasat University: lead
• Wörwag Pharma GmbH & Co. KG: collaborator

Study Sites (1)

Thammasat University Hospital

Pathumthani, Bangkok, 12120, Thailand

RECRUITING

Related Publications (11)

• 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.

  PMID: 38333576 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.

  PMID: 41257214 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.

  PMID: 16199253 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.

  PMID: 34547367 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.

  PMID: 20188835 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.

  PMID: 38034619 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.

  PMID: 22446172 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.

  PMID: 15726875 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.

  PMID: 18473286 BACKGROUND

MeSH Terms

Interventions

benphothiamine

Study Officials

• Supitcha Lamlertpanya

  Faculty of pharmacy Thammasat

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Supitcha Lamlertpanya

CONTACT

+66972723880; supicha.lam0901@gmail.com

Arom Jedsadayanmata

CONTACT

+6629869214; aromj@tu.ac.th

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 16, 2026
• Study Start: July 14, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)