Effects of Benfotiamine on Intraepidermal Nerve Fiber Density (IENFD)

Diabetic Neuropathies Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01868191
• Other study ID #: WOE_2013_SB
• Status: Not yet recruiting
• Phase: Phase 3
• First received: May 25, 2013
• Last updated: May 30, 2013
• Start date: July 2013
• Est. completion date: December 2014

Study information

• Verified date: May 2013
• Source: Diabetes Schwerpunktpraxis
• Contact: Alin O Stirban, MD, PhD
• Phone: +4921314018
• Email: alin.stirban[@]profil.com
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetic Neuropathies

Intervention

Drug:
• Benfotiamine
Treatment with 600 mg/day for the first 3 months followed by 300 mg/day for 9 months
• Placebo for benfotiamine
Treatment with placebo for benfotiamine 600 mg/day for the first 3 months followed by 300 mg/day for 9 months

Locations

Country	Name	City	State
Germany	Diabetes Schwerpunktpraxis	Essen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Diabetes Schwerpunktpraxis	Woerwag Pharma GmbH and Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in intraepidermal nerve fiber density		6 and 12 months	No
Secondary	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	No
Secondary	Change in neuropathic deficits	A score will be calculated at each timepoint using the Michigan Neuropathy Screening Instrument	3, 6 and 12 months	No