Status:
UNKNOWN
Effects of Benfotiamine on Intraepidermal Nerve Fiber Density (IENFD)
Lead Sponsor:
Diabetes Schwerpunktpraxis
Collaborating Sponsors:
Woerwag Pharma GmbH & Co. KG
Conditions:
Diabetic Neuropathies
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 neur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01868191
Start Date
July 1 2013
End Date
December 1 2014
Last Update
June 4 2013
Active Locations (1)
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1
Diabetes Schwerpunktpraxis
Essen, North Rhine-Westphalia, Germany, 45136