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.

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.

Study Overview

• Status: Unknown
• Conditions: Diabetic Neuropathies
• Intervention / Treatment: Drug: Placebo for benfotiamine; Drug: Benfotiamine

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Alin O Stirban, MD, PhD; Phone Number: 486 +4921314018; Email: alin.stirban@profil.com

Study Locations

• Germany
  • NRW
    • Essen, NRW, Germany, 45136
      • Diabetes Schwerpunktpraxis
      • Contact: Helga Zeller-Stefan, MD; Phone Number: +492011788892; Email: helga.zeller@gmx.de
      • Principal Investigator: Alin O Stirban, MD, PhD
      • Sub-Investigator: Helga Zeller-Stefan, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Milgamma protekt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in intraepidermal nerve fiber density	6 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in neuropathic symptoms	Following questionnaires will be used to assess neuropathic symptoms: modified Toronto Clinical Neuropathy Score and Michigan Neuropathy Screening Instrument	3, 6 and 12 months
Change in neuropathic deficits	A score will be calculated at each timepoint using the Michigan Neuropathy Screening Instrument	3, 6 and 12 months

Collaborators and Investigators

• Sponsor: Diabetes Schwerpunktpraxis
• Collaborators: Woerwag Pharma GmbH & Co. KG
• Investigators: Principal Investigator: Alin O Stirban, MD, PhD, Diabetes Schwerpunktpraxis

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: May 25, 2013
• First Submitted That Met QC Criteria: May 30, 2013
• First Posted (Estimate): June 4, 2013

Study Record Updates

• Last Update Posted (Estimate): June 4, 2013
• Last Update Submitted That Met QC Criteria: May 30, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Diabetes; Neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunologic Factors; Micronutrients; Adjuvants, Immunologic; Vitamins; Vitamin B Complex; Chelating Agents; Sequestering Agents; Thiamine; Benphothiamine
• Other Study ID Numbers: WOE_2013_SB