Diabetic Peripheral NeuropathyPhase 2/3DE-DPNNCT02332005
12-Month Efficacy and Safety of Diepalrestat in Adults With Diabetic Peripheral Neuropathy, a DB, Placebo-Controlled Study
A Phase 2/3 study testing diepalrestat choline in people with Diabetic Peripheral Neuropathy, run by NeuromaxBionevia at 27 sites in Russia.
Trial summary
An interventional study to investigate the efficacy and safety of diepalrestat (BNV-222) in diabetic patients with diabetic peripheral neuropathy. Subjects will receive twice daily an oral dose of diepalrestat, an aldose reductase inhibitor, or placebo to investigate the effect on motor nerve conduction velocity… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- diepalrestat choline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 27 sitesRussia
- Study dates
- Nov 2014to Nov 2017
- Phase
- Phase 2/3
- 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
- Patients with type 1 or type 2 diabetes mellitus that is controlled by oral or parenteral hypoglycemic agents or diet.
- Patients with diabetes that is stable and controlled (HbA1C ≤ than 10 %) with no new symptoms associated with diabetes within previous 3 months.
- Patients diagnosed with neuropathy who have abnormalities in 2 of 3 categories (signs, symptoms, and objective tests of nerve conduction studies or quantitative sensory threshold testing).
- Patients on pain medication (prescribed analgesics), stable for at least 3 months before study entry or pain treatment naive.
- Patients with at least mild painful symptoms of diabetic neuropathy for at least 1 year duration, but not longer than 10 years duration.
- Able to withstand the fundus evaluation during ophthalmology testing
Who cannot join
- A condition that would preclude a patient for participation in the study in opinion of investigator, e.g., unstable medical status including glycemic control and blood pressure.
- Any neurological disorder that may confound assessment of diabetic peripheral neuropathy such as radiculopathies. multiple sclerosis, myelopathies.
- Ongoing severe peripheral arterial diseases, skin ulcers, or amputation in the lower extremities.
- Neuropathy findings due to any of the following: alcohol abuse, liver or renal disease, toxic exposure, endocrine, metabolic or nutritional disorders, inflammatory diseases, or monoclonal gammopathies.
- Patients with absent peroneal nerve response.
- Other pain that may confound assessment of neuropathic pain.
- Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Russia27 sites
Northern State Medical University
Arkhangelsk, 163000
Health Services Severstal
Cherepovets, 162600
Kemerovo Regional Clinical Hospital
Kemerovo, 650066
Endocrinology Dispensary
Moscow, 119034
Morozovskaya Children City Hospital of Moscow
Moscow, 119049
I M Sechenov First Moscow State Medical University
Moscow, 119435
IM Sechenov First Moscow State Medical University
Moscow, 119435
IM Sechenov First Moscow State Medical University
Moscow, 119991
City Clinical Hospital No 71
Moscow, 121374
Central Clinical Hospital No 1 of JSC Russian Railway
Moscow, 125367
City Clinical Hospital No 50
Moscow, 127206
The Federal Bureau of Medical and Social Expertise
Moscow, 127486
Perm State Medical Academy
Perm, 614107
VA Baranov Respublical Hospital
Petrozavodsk, 185019
Rostov State Medical University
Rostov-on-Don, 344022
City Hospital No 40 of the Kurortny District
Saint Petersburg, Sestroretsk, 197706
Imc Sogaz
Saint Petersburg, 191186
Medical Center Reavita
Saint Petersburg, 194295
City Hospital of the Holy Martyr Elizabeth
Saint Petersburg, 195257
Nikolaev Hospital
Saint Petersburg, 198510
City Polyclinic No 20
Saratov, 410053
Bashkir State Medical University
Ufa, 450000
Central City Clinical Hospital
Ulyanovsk, 432057
State Medical University
Volgograd, 400131
Regional Clinical Hospital
Yaroslavl, 150000
NV Solovyov Clinical Emergency Hospital
Yaroslavl, 150003
Clinic of Neurology
Yekaterinburg, 620014
About this study
Official title: Twelve-Month Chronic Efficacy and Safety of Diepalrestat in Adult Subjects With Diabetic Peripheral Neuropathy (DPN), A Randomized, Double-Blind, Placebo-Controlled Study
An interventional study to investigate the efficacy and safety of diepalrestat (BNV-222) in diabetic patients with diabetic peripheral neuropathy. Subjects will receive twice daily an oral dose of diepalrestat, an aldose reductase inhibitor, or placebo to investigate the effect on motor nerve conduction velocity (MNCV) and symptomatic clinical responses over 12 months of treatment. Subjects will be assessed at screening and baseline, with office visits every 12 weeks, for a total of 6 visits. The study will explore in a double-blind fashion, the effect of two doses of diepalrestat, 150 and 300 mg, to reduce the loss in nerve conduction velocity that is expected to be demonstrated in the group randomized to placebo treatment for up to 12 months.
Read the detailed description
This 12 month double-blind, randomized, placebo-controlled, parallel group efficacy and safety study will enroll 400 adult diabetic subjects with diabetic peripheral neuropathy (DPN) to investigate the effect of diepalrestat (BNV-222) 150 mg, 300 mg, or placebo on MNCV and patients' perception of nerve function over 12 months as measured by VAS scales and composite clinical outcome patient reported scales that evaluate numbness, tingling, cramping, paresthesiae, hyperesthesia, coldness, weakness and spontaneous pain perception of upper and lower extremities, and the effects on other measures of nerve motor and sensory conduction. Subjects will be assessed at screening and baseline, with office visits every 12 weeks, for a total of 6 visits. Subjects will be assessed by testing motor nerve conduction velocity and other assessments at each office visit. A subgroup of 24 patients will be selected for pharmacokinetic (PK) testing for up to 48 hours with additional blood draws on Day 7 and 14. This study will investigate the ability of diepalrestat to reduce the ongoing deterioration of nerve function which is a hallmark of the DPN process.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- diepalrestat choline, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diepalrestat cholineDrug
Also called BNV-222
aldose reductase inhibitor
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 150 mg | Active comparator | 150 mg diepalrestat choline administered as twice daily dosing morning and evening with an oral tablet of either 150 mg diepalrestat choline or placebo Receives: Drug: diepalrestat choline |
| Group 2 300 mg | Active comparator | 300 mg diepalrestat choline administered as twice daily dosing morning and evening with an oral tablet of 150 mg diepalrestat choline Receives: Drug: diepalrestat choline |
| Group 3 | Placebo comparator | Tablet administered twice daily morning and evening containing placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in peroneal motor nerve conduction velocity
Measured: 12 months
Secondary outcomes (7)
change from baseline in patient-reported Visual Acuity Scales
Patients' perception of pain, numbness, tingling, weakness of the foot, ataxia, upper limb symptoms and sensory symptoms assessed by pinprick, light touch, vibration, and temperature
Measured: 12 months
change from baseline in patient-reported responses to Toronto Clinical Neuropathy Score (TCNS)
TCNS component measures of symptomatic changes in pain, numbness and other measures
Measured: 12 months
change from baseline in quality of life administered by SF-36 instrument
patient global impression of quality of life assessed by the SF-36 short form
Measured: 12 months
change from baseline in median conduction velocity measurements
conduction velocity measures including median MNCV,
Measured: 12 months
change in visual acuity compared to baseline
Change in visual acuity over 12 months compared to baseline, change in diabetic retinopathy in the dilated eye
Measured: 12 months
change from baseline in MFWL conduction velocity measurement
change from baseline in median F wave latency (MFWL)
Measured: 12 months
change from baseline in VPT conduction velocity measurement
change from baseline in Vibration Perception Threshold (VPT)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuromaxBionevia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julia Mockot, MD, Study director, NeuroMax Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332005
- Sponsor's protocol ID
- NM-ARI-231
- Acronym
- DE-DPN
- Status last verified
- Sep 2018
- First submitted
- 2 Jan 2015
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twelve-Month Chronic Efficacy and Safety of Diepalrestat in Adult Subjects With Diabetic Peripheral Neuropathy (DPN), A Randomized, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT02332005
- Acronym / sponsor ID
- DE-DPN / NM-ARI-231
- Conditions
- Diabetic Peripheral Neuropathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- NeuromaxBioneviaIndustry (pharma, biotech, devices)
- Study start
- Nov 2014 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 6 Jan 2015 (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.
An interventional study to investigate the efficacy and safety of diepalrestat (BNV-222) in diabetic patients with diabetic peripheral neuropathy. Subjects will receive twice daily an oral dose of diepalrestat, an aldose reductase inhibitor, or placebo to investigate the effect on motor nerve conduction velocity (MNCV) and symptomatic clinical responses over 12 months of treatment. Subjects will be assessed at screening and baseline, with office visits every 12 weeks, for a total of 6 visits. The study will explore in a double-blind fashion, the effect of two doses of diepalrestat, 150 and 300 mg, to reduce the loss in nerve conduction velocity that is expected to be demonstrated in the group randomized to placebo treatment for up to 12 months.
Detailed description
This 12 month double-blind, randomized, placebo-controlled, parallel group efficacy and safety study will enroll 400 adult diabetic subjects with diabetic peripheral neuropathy (DPN) to investigate the effect of diepalrestat (BNV-222) 150 mg, 300 mg, or placebo on MNCV and patients' perception of nerve function over 12 months as measured by VAS scales and composite clinical outcome patient reported scales that evaluate numbness, tingling, cramping, paresthesiae, hyperesthesia, coldness, weakness and spontaneous pain perception of upper and lower extremities, and the effects on other measures of nerve motor and sensory conduction. Subjects will be assessed at screening and baseline, with office visits every 12 weeks, for a total of 6 visits. Subjects will be assessed by testing motor nerve conduction velocity and other assessments at each office visit. A subgroup of 24 patients will be selected for pharmacokinetic (PK) testing for up to 48 hours with additional blood draws on Day 7 and 14. This study will investigate the ability of diepalrestat to reduce the ongoing deterioration of nerve function which is a hallmark of the DPN process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 150 mg | Active comparator | Drug: diepalrestat choline150 mg diepalrestat choline administered as twice daily dosing morning and evening with an oral tablet of either 150 mg diepalrestat choline or placebo |
| Group 2 300 mg | Active comparator | Drug: diepalrestat choline300 mg diepalrestat choline administered as twice daily dosing morning and evening with an oral tablet of 150 mg diepalrestat choline |
| Group 3 | Placebo comparator | Drug: PlaceboTablet administered twice daily morning and evening containing placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with type 1 or type 2 diabetes mellitus that is controlled by oral or parenteral hypoglycemic agents or diet.
- Patients with diabetes that is stable and controlled (HbA1C ≤ than 10 %) with no new symptoms associated with diabetes within previous 3 months.
- Patients diagnosed with neuropathy who have abnormalities in 2 of 3 categories (signs, symptoms, and objective tests of nerve conduction studies or quantitative sensory threshold testing).
- Patients on pain medication (prescribed analgesics), stable for at least 3 months before study entry or pain treatment naive.
- Patients with at least mild painful symptoms of diabetic neuropathy for at least 1 year duration, but not longer than 10 years duration.
Key exclusion criteria (7 listed)
- A condition that would preclude a patient for participation in the study in opinion of investigator, e.g., unstable medical status including glycemic control and blood pressure.
- Any neurological disorder that may confound assessment of diabetic peripheral neuropathy such as radiculopathies. multiple sclerosis, myelopathies.
- Ongoing severe peripheral arterial diseases, skin ulcers, or amputation in the lower extremities.
- Neuropathy findings due to any of the following: alcohol abuse, liver or renal disease, toxic exposure, endocrine, metabolic or nutritional disorders, inflammatory diseases, or monoclonal gammopathies.
- Patients with absent peroneal nerve response.
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 |
|---|---|---|
| diepalrestat cholineAlso: BNV-222aldose reductase inhibitor | Drug | Group 1 150 mg, Group 2 300 mg |
| PlaceboPlacebo | Drug | Group 3 |
Primary outcome
change from baseline in peroneal motor nerve conduction velocity
Time frame: 12 months
7 secondary outcomes
change from baseline in patient-reported Visual Acuity Scales
Time frame: 12 months
change from baseline in patient-reported responses to Toronto Clinical Neuropathy Score (TCNS)
Time frame: 12 months
change from baseline in quality of life administered by SF-36 instrument
Time frame: 12 months
change from baseline in median conduction velocity measurements
Time frame: 12 months
change in visual acuity compared to baseline
Time frame: 12 months
change from baseline in MFWL conduction velocity measurement
Time frame: 12 months
change from baseline in VPT conduction velocity measurement
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Individual participant dataSharing planned: Yes
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Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
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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.
Julia Mockot, MD study director
NeuroMax Ltd.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing diepalrestat choline in people with Diabetic Peripheral Neuropathy, run by NeuromaxBionevia at 27 sites in Russia.
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: finished, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Russia. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in peroneal motor nerve conduction velocity (time frame: 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 27 Sep 2018.