Effects of benfotiamine treatment over 12 months on morphometric, neurophysiological and clinical measures in type 2 diabetes patients with symptomatic polyneuropathy: a randomized, placebo-controlled, double-blind clinical trial (BOND study)
Authors' conclusion
In type 2 diabetes individuals with mild-to-moderate symptomatic DSPN, treatment with benfotiamine for 12 months was well tolerated, but had no significant effects on multiple morphometric, neurophysiological and clinical measures of neuropathy.
Study context
- Population
- Participants with T2D and mild-to-moderate symptomatic diabetic sensorimotor polyneuropathy (DSPN)randomized
- Participants
- 57 participants
- Comparison
- Benfotiamine 300 mg twice daily vs placebo for 12 months
- Primary endpoint
- Change in corneal nerve fiber length (CNFL) assessed by corneal confocal microscopy
- Follow-up
- Baseline to 12 months
Methodological details1:1 randomized, double-blind, placebo-controlled, parallel group, monocentric, phase II
- 1:1 randomized
- Double-blind
- Placebo-controlled
- Parallel group
- Monocentric
- Phase II
Primary result
As reported in the abstract
Change in CNFL
- Changes in corneal nerve fiber length (CNFL) did not differ between the two groups
Secondary outcomes
| Outcome | P value |
|---|---|
| Neuropathy Symptom ScoreTended to improve after benfotiamine | P = 0.098 vs placebo |
| Blood concentrations of six thiamine analytesIncreased with benfotiamine for all six analytes | P ≤ 0.003 vs placebo |
Secondary morphometric, functional and clinical neuropathic outcomes and quality of life · baseline to 12 months
- Changes similar in the two groups
Safety
- No relevant differences between the groups in rates of adverse events
Original publication
Effects of benfotiamine treatment over 12 months on morphometric, neurophysiological and clinical measures in type 2 diabetes patients with symptomatic polyneuropathy: a randomized, placebo-controlled, double-blind clinical trial (BOND study). BMJ Open Diabetes Res Care. Published 22 January 2026. doi:10.
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