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

ConditionDiabetic Peripheral Neuropathy (DPN)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThammasat University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

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.

Disqualifiers

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.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: BenfotiamineExperimental treatment 1 intervention
Group B: Vitamin B 1-6-12Active comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Mean change of numbness score

Numbness was assessed using a Numerical Rating Scale (NRS). The numbness scale underwent content validity assessment by three experts and achieved an Item-Objective Congruence (IOC) score of 1.0. Scores range from 0 to 10, with higher scores indicating greater numbness severity.

Time frame
From enrollment to the end of treatment at 12 weeks
2

Mean change numerical rating scale for pain

Pain was assessed using a Numerical Rating Scale (NRS). Scores range from 0 to 10, with higher scores indicating greater pain severity.

Time frame
From enrollment to 4, 8 and 12 weeks of treatment at
3

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

Time frame
From enrollment to the end of treatment at 12 weeks

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Thammasat University HospitalRecruiting12120, Pathumthani, BangkokThailandThailand

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thammasat University

Lead sponsor

Wörwag Pharma GmbH & Co. KG

Collaborator

Source ClinicalTrials.gov
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