Clinical trial NCT01868191: Effects of Benfotiamine on Intraepidermal Nerve Fiber Density (IENFD)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetic Neuropathies
Keywords: Diabetes
Neuropathy
Lead sponsor: Diabetes Schwerpunktpraxis
Sponsor class: OTHER
Collaborators: name: Woerwag Pharma GmbH & Co. KG
First posted: 2013-06-04
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in intraepidermal nerve fiber density
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Change in neuropathic symptoms
timeFrame: 3, 6 and 12 months
measure: Change in neuropathic deficits
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Diabetes Schwerpunktpraxis
state: NRW
Study officials:
affiliation: Diabetes Schwerpunktpraxis
name: Alin O Stirban, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: