Effects of Benfotiamine on Intraepidermal Nerve Fiber Density (IENFD)

NCT01868191 | Unknown Phase 3

• 1 other identifier: WOE_2013_SB
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Neuropathies

Keywords

Diabetes; Neuropathy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in intraepidermal nerve fiber density

  6 and 12 months

Secondary Outcomes (2)

• Change in neuropathic symptoms

  3, 6 and 12 months

• Change in neuropathic deficits

  3, 6 and 12 months

Study Arms (2)

Placebo for benfotiamine

PLACEBO COMPARATOR

Placebo for benfotiamine 600 mg/day for the first 3 months followed by 300 mg/day for 9 months

Drug: Placebo for benfotiamine

Benfotiamine

EXPERIMENTAL

Treatment with benfotiamine 600 mg/day for 3 months followed by 300 mg/day for 9 months

Drug: Benfotiamine

Interventions

Benfotiamine DRUG

Treatment with 600 mg/day for the first 3 months followed by 300 mg/day for 9 months

Also known as: Milgamma protekt

Benfotiamine

Placebo for benfotiamine DRUG

Treatment with placebo for benfotiamine 600 mg/day for the first 3 months followed by 300 mg/day for 9 months

Placebo for benfotiamine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diabetes Schwerpunktpraxis: lead
• Woerwag Pharma GmbH & Co. KG: collaborator

Study Sites (1)

Diabetes Schwerpunktpraxis

Essen, North Rhine-Westphalia, 45136, Germany

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus

Interventions

benphothiamine

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alin O Stirban, MD, PhD

  Diabetes Schwerpunktpraxis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alin O Stirban, MD, PhD

CONTACT

+4921314018; alin.stirban@profil.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: May 25, 2013
• First Posted: June 4, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 4, 2013

Record last verified: 2013-05

Locations

DE (1)