Effects of Benfotiamine on Intraepidermal Nerve Fiber Density (IENFD)

Phase 3

• Conditions: Diabetic Neuropathies
• Interventions: Drug: Benfotiamine; Drug: Placebo for benfotiamine

• Registration Number: NCT01868191
• Lead Sponsor: Diabetes Schwerpunktpraxis

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-05
• Study First Submitted: 2013-05-25
• Study First Submitted QC: 2013-05-30
• Last Update Submitted: 2013-05-30
• Study First Posted: 2013-06-04
• Last Update Posted: 2013-06-04
• Study Start: 2013-07
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Benfotiamine	Benfotiamine	Treatment with benfotiamine 600 mg/day for 3 months followed by 300 mg/day for 9 months
Placebo for benfotiamine	Placebo for benfotiamine	Placebo for benfotiamine 600 mg/day for the first 3 months followed by 300 mg/day for 9 months

Primary Outcome Measures

Name	Time	Method
Change from baseline in intraepidermal nerve fiber density	6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Change in neuropathic deficits	3, 6 and 12 months	A score will be calculated at each timepoint using the Michigan Neuropathy Screening Instrument
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

Trial Locations

Locations (1)

Diabetes Schwerpunktpraxis; 🇩🇪 Essen, NRW, Germany