Diabetic NeuropathiesPhase 3NCT01868191
Effects of Benfotiamine on Intraepidermal Nerve Fiber Density (IENFD)
A Phase 3 study testing Benfotiamine in people with Diabetic Neuropathies, run by Diabetes Schwerpunktpraxis at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- Benfotiamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Diabetes Schwerpunktpraxis
Essen, North Rhine-Westphalia, 45136
Helga Zeller-Stefan, MD, +492011788892, helga.zeller@gmx.de
Alin O Stirban, MD, PhD
About this study
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.
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
- Being tested
- Benfotiamine, Placebo for benfotiamine
- Keywords
- Diabetes, Neuropathy
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenfotiamineDrug
Also called Milgamma protekt
Treatment with 600 mg/day for the first 3 months followed by 300 mg/day for 9 months
Placebo for benfotiamineDrug
Treatment with placebo for benfotiamine 600 mg/day for the first 3 months followed by 300 mg/day for 9 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo for benfotiamine | Placebo comparator | Placebo for benfotiamine 600 mg/day for the first 3 months followed by 300 mg/day for 9 months Receives: Drug: Placebo for benfotiamine |
| Benfotiamine | Experimental | Treatment with benfotiamine 600 mg/day for 3 months followed by 300 mg/day for 9 months Receives: Drug: Benfotiamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in intraepidermal nerve fiber density
Measured: 6 and 12 months
Secondary outcomes (2)
Change in neuropathic symptoms
Following questionnaires will be used to assess neuropathic symptoms: modified Toronto Clinical Neuropathy Score and Michigan Neuropathy Screening Instrument
Measured: 3, 6 and 12 months
Change in neuropathic deficits
A score will be calculated at each timepoint using the Michigan Neuropathy Screening Instrument
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diabetes Schwerpunktpraxis
- Sponsor type
- University, hospital or other
- Collaborators
- Woerwag Pharma GmbH & Co. KG
- Responsible party
- Principal investigator, Ovidiu Alin Stirban, Diabetes Schwerpunktpraxis
- Investigators
- Alin O Stirban, MD, PhD, Principal investigator, Diabetes Schwerpunktpraxis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868191
- Sponsor's protocol ID
- WOE_2013_SB
- Status last verified
- May 2013
- First submitted
- 25 May 2013
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01868191
- Acronym / sponsor ID
- WOE_2013_SB
- Conditions
- Diabetic Neuropathies
- Keywords
- Diabetes, Neuropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Diabetes SchwerpunktpraxisUniversity, hospital or other
- Collaborators
- Woerwag Pharma GmbH & Co. KG
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo for benfotiamine | Placebo comparator | Drug: Placebo for benfotiaminePlacebo for benfotiamine 600 mg/day for the first 3 months followed by 300 mg/day for 9 months |
| Benfotiamine | Experimental | Drug: BenfotiamineTreatment with benfotiamine 600 mg/day for 3 months followed by 300 mg/day for 9 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BenfotiamineAlso: Milgamma protektTreatment with 600 mg/day for the first 3 months followed by 300 mg/day for 9 months | Drug | Benfotiamine |
| Placebo for benfotiamineTreatment with placebo for benfotiamine 600 mg/day for the first 3 months followed by 300 mg/day for 9 months | Drug | Placebo for benfotiamine |
Primary outcome
Change from baseline in intraepidermal nerve fiber density
Time frame: 6 and 12 months
2 secondary outcomes
Change in neuropathic symptoms
Time frame: 3, 6 and 12 months
Change in neuropathic deficits
Time frame: 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alin O Stirban, MD, PhD principal investigator
Diabetes Schwerpunktpraxis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Benfotiamine in people with Diabetic Neuropathies, run by Diabetes Schwerpunktpraxis at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alin O Stirban, MD, PhD (+4921314018 ext. 486, alin.stirban@profil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in intraepidermal nerve fiber density (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2013.