Effects of Benfotiamine on Intraepidermal Nerve Fiber Density (IENFD)

Study Overview
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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.

Official Title
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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.

Conditions
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Diabetic Neuropathies

Intervention / Treatment
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* Drug: Benfotiamine
* Drug: Placebo for benfotiamine


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo for benfotiamine<br>Placebo for benfotiamine 600 mg/day for the first 3 months followed by 300 mg/day for 9 months | Drug: Placebo for benfotiamine<br>* Treatment with placebo for benfotiamine 600 mg/day for the first 3 months followed by 300 mg/day for 9 months<br>|
| Experimental: Benfotiamine<br>Treatment with benfotiamine 600 mg/day for 3 months followed by 300 mg/day for 9 months | Drug: Benfotiamine<br>* Treatment with 600 mg/day for the first 3 months followed by 300 mg/day for 9 months<br>* Other names: Milgamma protekt;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in intraepidermal nerve fiber density |  | 6 and 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Neuropathy