Effects of Benfotiamine on Intraepidermal Nerve Fiber Density (IENFD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetic Neuropathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo for benfotiamine

Placebo for benfotiamine 600 mg/day for the first 3 months followed by 300 mg/day for 9 months

Group Type PLACEBO_COMPARATOR

Placebo for benfotiamine

Intervention Type DRUG

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

Benfotiamine

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

Group Type EXPERIMENTAL

Benfotiamine

Intervention Type DRUG

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

Interventions

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Benfotiamine

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Milgamma protekt

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No