NCT01868191UnknownPhase 3
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.
Diabetes Schwerpunktpraxis1 site in 1 country22 target enrollmentStarted: July 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Change from baseline in intraepidermal nerve fiber density
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- 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.
Arms & Interventions
Placebo for benfotiamine
Placebo Comparator
Placebo for benfotiamine 600 mg/day for the first 3 months followed by 300 mg/day for 9 months
Intervention: Placebo for benfotiamine (Drug)
Benfotiamine
Experimental
Treatment with benfotiamine 600 mg/day for 3 months followed by 300 mg/day for 9 months
Intervention: Benfotiamine (Drug)
Outcomes
Primary Outcomes
Change from baseline in intraepidermal nerve fiber density
Time Frame: 6 and 12 months
Secondary Outcomes
- Change in neuropathic deficits(3, 6 and 12 months)
- Change in neuropathic symptoms(3, 6 and 12 months)
Investigators
Ovidiu Alin Stirban
Dr. med.
Diabetes Schwerpunktpraxis
Study Sites (1)
Loading locations...
Similar Trials
Active, not recruiting
Phase 1
Effects of benfotiamine treatment over 12 months on variables of peripheral diabetic neuropathyDiabetic neuropathyMedDRA version: 14.1Level: LLTClassification code 10036113Term: Polyneuropathy in diabetesSystem Organ Class: 100000004852EUCTR2013-001058-85-DEWörwag Pharma GmbH & Co. KG
Unknown
Phase 4
Chronic Treatment With Benfotiamine Restores Endothelial Function in People With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT00446810Ruhr University of Bochum30
Completed
Not Applicable
Pre-study to Evaluate IENFD Induction in Patients With Taxane-induced CIPNPeripheral Nervous System DiseasesNCT05133947Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.24
Completed
Phase 4
Benfotiamine in Diabetic NephropathyDiabetic NephropathyNCT00565318University Medical Center Groningen86
Recruiting
Not Applicable
Neuroimaging Study on the Effect of Transdermal Buprenorphine in Complex Regional Pain Syndrome PatientsComplex Regional Pain SyndromesNCT03977012Seoul National University Hospital20