Benfotiamine vs. B1-6-12 for diabetic nerve pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 4, double-blind, randomized study comparing benfotiamine to vitamin B1-6-12 in adults with diabetic peripheral neuropathy. Participants are screened for vitamin B12 deficiency before enrollment, and medications for neuropathic pain must be stable prior to joining. Both treatments are provided as visually identical pills to maintain blinding. Outcomes focus on changes in sensory neuropathy symptoms, numbness, and pain, assessed by established measures such as NTSS-6. The trial is led by Thammasat University with Wörwag Pharma as a collaborator at a center in Bangkok, Thailand.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Adjustment of glucose-lowering medication doses or HbA1c \>8% within 3 months prior to study enrollment.
* Pregnancy, planned pregnancy within 3 months, or currently breastfeeding.
* Inability to attend scheduled study visits in person or through telemedicine follow-up as required by the study protocol.
* Known allergy or hypersensitivity to benfotiamine or any component of benfotiamine, vitamin B1, vitamin B6, or vitamin B12.
* Previous use of benfotiamine and/or vitamin B1-6-12 discontinued less than 7 days before study enrollment.
* Current use of vitamin B6 supplementation or medications containing vitamin B6 at a dose \>100 mg/day.

Where it's running

• Thammasat University Hospital
  Pathumthani, Bangkok, Thailand Recruiting

Study contacts

• Principal investigator: Supitcha Lamlertpanya — Faculty of pharmacy Thammasat
• Study coordinator: Supitcha Lamlertpanya
• Email: supicha.lam0901@gmail.com
• Phone: +66972723880

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.