Effects of Benfotiamine on Intraepidermal Nerve Fiber Density (IENFD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2013 by Diabetes Schwerpunktpraxis.
Recruitment status was  Not yet recruiting
Woerwag Pharma GmbH and Co. KG
Information provided by (Responsible Party):
Ovidiu Alin Stirban, Diabetes Schwerpunktpraxis
ClinicalTrials.gov Identifier:
First received: May 25, 2013
Last updated: May 30, 2013
Last verified: May 2013
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.

Condition Intervention Phase
Diabetic Neuropathies
Drug: Benfotiamine
Drug: Placebo for benfotiamine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Diabetes Schwerpunktpraxis:

Primary Outcome Measures:
  • Change from baseline in intraepidermal nerve fiber density [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in neuropathic symptoms [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
    Following questionnaires will be used to assess neuropathic symptoms: modified Toronto Clinical Neuropathy Score and Michigan Neuropathy Screening Instrument

  • Change in neuropathic deficits [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
    A score will be calculated at each timepoint using the Michigan Neuropathy Screening Instrument

Estimated Enrollment: 22
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo for benfotiamine
Placebo for benfotiamine 600 mg/day for the first 3 months followed by 300 mg/day for 9 months
Drug: Placebo for benfotiamine
Treatment with placebo for benfotiamine 600 mg/day for the first 3 months followed by 300 mg/day for 9 months
Experimental: Benfotiamine
Treatment with benfotiamine 600 mg/day for 3 months followed by 300 mg/day for 9 months
Drug: Benfotiamine
Treatment with 600 mg/day for the first 3 months followed by 300 mg/day for 9 months
Other Name: Milgamma protekt


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01868191

Contact: Alin O Stirban, MD, PhD +4921314018 ext 486 alin.stirban@profil.com

Diabetes Schwerpunktpraxis Not yet recruiting
Essen, NRW, Germany, 45136
Contact: Helga Zeller-Stefan, MD    +492011788892    helga.zeller@gmx.de   
Principal Investigator: Alin O Stirban, MD, PhD         
Sub-Investigator: Helga Zeller-Stefan, MD, PhD         
Sponsors and Collaborators
Diabetes Schwerpunktpraxis
Woerwag Pharma GmbH and Co. KG
Principal Investigator: Alin O Stirban, MD, PhD Diabetes Schwerpunktpraxis
  More Information

Responsible Party: Ovidiu Alin Stirban, Dr. med., Diabetes Schwerpunktpraxis
ClinicalTrials.gov Identifier: NCT01868191     History of Changes
Other Study ID Numbers: WOE_2013_SB 
Study First Received: May 25, 2013
Last Updated: May 30, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Diabetes Schwerpunktpraxis:

Additional relevant MeSH terms:
Diabetic Neuropathies
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
Adjuvants, Immunologic
Chelating Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sequestering Agents

ClinicalTrials.gov processed this record on May 26, 2016