Title
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.
Phase
Phase 3Lead Sponsor
Diabetes SchwerpunktpraxisStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Diabetic NeuropathiesIntervention/Treatment
thiamine ...Study Participants
22The 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.
Treatment with 600 mg/day for the first 3 months followed by 300 mg/day for 9 months
Treatment with placebo for benfotiamine 600 mg/day for the first 3 months followed by 300 mg/day for 9 months
Treatment with benfotiamine 600 mg/day for 3 months followed by 300 mg/day for 9 months
Placebo for benfotiamine 600 mg/day for the first 3 months followed by 300 mg/day for 9 months
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.
