NCT01868191

Effects of Benfotiamine on Intraepidermal Nerve Fiber Density (IENFD)

Effects of Benfotiamine on Intraepidermal Nerve Fiber Density (IENFD)and Diabetic Neuropathy in Subjects With Sensorimotor Diabetic Polyneuropathy: a Double-blind, Randomized, Placebo-controlled Parallel Group Pilot Study Over 12 Months.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Diabetes Schwerpunktpraxis · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of the present study is to assess before, as well as 6 and 12 months following a therapy with benfotiamine the influence of therapy on intraepidermal nerve fiber density (skin biopsy) and neuropathic symptoms and deficits in people with type 1 or 2 diabetes mellitus and diabetic sensomotoric neuropathy.

Conditions

• Diabetic Neuropathies

Interventions

Type	Name	Description
DRUG	Benfotiamine	Treatment with 600 mg/day for the first 3 months followed by 300 mg/day for 9 months
DRUG	Placebo for benfotiamine	Treatment with placebo for benfotiamine 600 mg/day for the first 3 months followed by 300 mg/day for 9 months

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-06-04
• Last updated: 2013-06-04

Locations

1 site across 1 country: Germany