Effects of Benfotiamine on Intraepidermal Nerve Fiber Density (IENFD)

Diabetes Schwerpunktpraxis

Status and phase: Unknown; Phase 3

Conditions: Diabetic Neuropathies

Treatments: Drug: Placebo for benfotiamine; Drug: Benfotiamine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01868191

WOE_2013_SB

Details and patient eligibility

About

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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups, including a placebo group

Placebo for benfotiamine

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo for benfotiamine

Benfotiamine

Experimental group

Description:

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

Treatment:

Drug: Benfotiamine