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Compares treatment options for Diabetic Peripheral Neuropathy (DPN)
Official title Benfotiamine Versus Vitamin B1-6-12 for Diabetic Peripheral Neuropathy
ClinicalTrials.gov ID: NCT07708233
What this study is testing
What is Benfotiamine?
Benfotiamine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for diabetic peripheral neuropathy (dpn).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Presence of sensory neuropathy symptoms assessed using the Neuropathy Total Symptom Score-6 (NTSS-6), with: Total NTSS-6 score ≥1; and Numbness...
- 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 likely can't join 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...
- 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...
- HIV/AIDS with any of the following: Current or previous treatment with didanosine, stavudine, or zalcitabine; CD4 count \ 1,000 copies/mL.
- Drug-induced polyneuropathy (ICD-10: G62.0).
See the full eligibility 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...
- 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.
- 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)...
- 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...
- HIV/AIDS with any of the following: Current or previous treatment with didanosine, stavudine, or zalcitabine; CD4 count \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Pathumthani, Bangkok, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pathumthani, Bangkok, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.