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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01868191

Enrollment

Registered

2013-06-04

Start date

2013-07-31

Completion date

2014-12-31

Last updated

2013-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathies

Keywords

Diabetes, Neuropathy

Brief 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.

Interventions

DRUGBenfotiamine

Treatment with 600 mg/day for the first 3 months followed by 300 mg/day for 9 months

DRUGPlacebo for benfotiamine

Treatment with placebo for benfotiamine 600 mg/day for the first 3 months followed by 300 mg/day for 9 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Have type 1 or type 2 diabetes mellitus based on the disease diagnostic criteria (WHO) classification on ongoing insulin or/and oral antidiabetic therapy with a stable regimen for the previous 3 months * Male or female subjects aged between 18 and 75 years, inclusive * Have an HbA1c level ≤ 9.5% without optimizing potential * mTCNS (modified Toronto Clinical Neuropathy Score) ≥ (above or equal to) 6) OR (a score on the MNSI (Michigan Neuropathy Screening Instrument)questionnaire of ≥4 or a score on the MNSI examination ≥2.5) * Medical history without major pathology (with the exception of type 2 diabetes) as judged by the investigator, especially no major peripheral artery disease. * Body mass index (BMI) between 25 and 45kg/m2, both inclusive

Exclusion criteria

* Subjects with secondary forms of diabetes such as due to pancreatitis. * Current or previous treatment (less than 6 months) with benfotiamine, B-vitamins, vitamin B complex, alpha lipoic acid or actovegin. * Have any contraindications, known allergy, or hypersensitivity to benfotiamine. * Have any contraindications, known allergy, or hypersensitivity to local anesthetics. * Neuropathy by other origin than diabetes. * Other severe pain that might impair the assessment of neuropathic pain. * Treatment with more than one of following: tricyclic antidepressants, serotonin norepinephrine reuptake inhibitors, anticonvulsants, class I antiarrhythmics with Na-channel inhibition (mexiletine, flecainid, propafenon and others) or neuroleptics in patients receiving these drugs for neuropathic pain.

Design outcomes

Primary

Measure	Time frame
Change from baseline in intraepidermal nerve fiber density	6 and 12 months

Secondary

Measure	Time frame	Description
Change in neuropathic symptoms	3, 6 and 12 months	Following questionnaires will be used to assess neuropathic symptoms: modified Toronto Clinical Neuropathy Score and Michigan Neuropathy Screening Instrument
Change in neuropathic deficits	3, 6 and 12 months	A score will be calculated at each timepoint using the Michigan Neuropathy Screening Instrument

Countries

Germany

Contacts

Primary ContactAlin O Stirban, MD, PhD

alin.stirban@profil.com+4921314018

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026