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12-Month Efficacy and Safety of Diepalrestat in Adults With Diabetic Peripheral Neuropathy, a DB, Placebo-Controlled Study (DE-DPN)

Primary Purpose

Diabetic Peripheral Neuropathy

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
diepalrestat choline
Placebo
Sponsored by
NeuromaxBionevia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • City Hospital No 40 of the Kurortny District
  • Northern State Medical University
  • Health Services Severstal
  • Clinic of Neurology
  • Kemerovo Regional Clinical Hospital
  • Endocrinology Dispensary
  • Morozovskaya Children City Hospital of Moscow
  • I M Sechenov First Moscow State Medical University
  • IM Sechenov First Moscow State Medical University
  • IM Sechenov First Moscow State Medical University
  • City Clinical Hospital No 71
  • Central Clinical Hospital No 1 of JSC Russian Railway
  • City Clinical Hospital No 50
  • The Federal Bureau of Medical and Social Expertise
  • Perm State Medical Academy
  • VA Baranov Respublical Hospital
  • Rostov State Medical University
  • City Polyclinic No 20
  • Imc Sogaz
  • Medical Center Reavita
  • City Hospital of the Holy Martyr Elizabeth
  • Nikolaev Hospital
  • Bashkir State Medical University
  • Central City Clinical Hospital
  • State Medical University
  • Regional Clinical Hospital
  • NV Solovyov Clinical Emergency Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group 1 150 mg

Group 2 300 mg

Group 3

Arm Description

150 mg diepalrestat choline administered as twice daily dosing morning and evening with an oral tablet of either 150 mg diepalrestat choline or placebo

300 mg diepalrestat choline administered as twice daily dosing morning and evening with an oral tablet of 150 mg diepalrestat choline

Tablet administered twice daily morning and evening containing placebo

Outcomes

Primary Outcome Measures

change from baseline in peroneal motor nerve conduction velocity

Secondary Outcome Measures

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
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
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
change from baseline in median conduction velocity measurements
conduction velocity measures including median MNCV,
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
change from baseline in MFWL conduction velocity measurement
change from baseline in median F wave latency (MFWL)
change from baseline in VPT conduction velocity measurement
change from baseline in Vibration Perception Threshold (VPT)

Full Information

First Posted
January 2, 2015
Last Updated
September 26, 2018
Sponsor
NeuromaxBionevia
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1. Study Identification

Unique Protocol Identification Number
NCT02332005
Brief Title
12-Month Efficacy and Safety of Diepalrestat in Adults With Diabetic Peripheral Neuropathy, a DB, Placebo-Controlled Study
Acronym
DE-DPN
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuromaxBionevia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 150 mg
Arm Type
Active Comparator
Arm Description
150 mg diepalrestat choline administered as twice daily dosing morning and evening with an oral tablet of either 150 mg diepalrestat choline or placebo
Arm Title
Group 2 300 mg
Arm Type
Active Comparator
Arm Description
300 mg diepalrestat choline administered as twice daily dosing morning and evening with an oral tablet of 150 mg diepalrestat choline
Arm Title
Group 3
Arm Type
Placebo Comparator
Arm Description
Tablet administered twice daily morning and evening containing placebo
Intervention Type
Drug
Intervention Name(s)
diepalrestat choline
Other Intervention Name(s)
BNV-222
Intervention Description
aldose reductase inhibitor
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
change from baseline in peroneal motor nerve conduction velocity
Time Frame
12 months
Secondary Outcome Measure Information:
Title
change from baseline in patient-reported Visual Acuity Scales
Description
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
Time Frame
12 months
Title
change from baseline in patient-reported responses to Toronto Clinical Neuropathy Score (TCNS)
Description
TCNS component measures of symptomatic changes in pain, numbness and other measures
Time Frame
12 months
Title
change from baseline in quality of life administered by SF-36 instrument
Description
patient global impression of quality of life assessed by the SF-36 short form
Time Frame
12 months
Title
change from baseline in median conduction velocity measurements
Description
conduction velocity measures including median MNCV,
Time Frame
12 months
Title
change in visual acuity compared to baseline
Description
Change in visual acuity over 12 months compared to baseline, change in diabetic retinopathy in the dilated eye
Time Frame
12 months
Title
change from baseline in MFWL conduction velocity measurement
Description
change from baseline in median F wave latency (MFWL)
Time Frame
12 months
Title
change from baseline in VPT conduction velocity measurement
Description
change from baseline in Vibration Perception Threshold (VPT)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Mockot, MD
Organizational Affiliation
NeuroMax Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
City Hospital No 40 of the Kurortny District
City
St Petersburg
State/Province
Sestroretsk
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
Northern State Medical University
City
Arkhangelsk
ZIP/Postal Code
163000
Country
Russian Federation
Facility Name
Health Services Severstal
City
Cherepovets
ZIP/Postal Code
162600
Country
Russian Federation
Facility Name
Clinic of Neurology
City
Ekaterinburg
ZIP/Postal Code
620014
Country
Russian Federation
Facility Name
Kemerovo Regional Clinical Hospital
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Endocrinology Dispensary
City
Moscow
ZIP/Postal Code
119034
Country
Russian Federation
Facility Name
Morozovskaya Children City Hospital of Moscow
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
I M Sechenov First Moscow State Medical University
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
Facility Name
IM Sechenov First Moscow State Medical University
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
Facility Name
IM Sechenov First Moscow State Medical University
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
City Clinical Hospital No 71
City
Moscow
ZIP/Postal Code
121374
Country
Russian Federation
Facility Name
Central Clinical Hospital No 1 of JSC Russian Railway
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
City Clinical Hospital No 50
City
Moscow
ZIP/Postal Code
127206
Country
Russian Federation
Facility Name
The Federal Bureau of Medical and Social Expertise
City
Moscow
ZIP/Postal Code
127486
Country
Russian Federation
Facility Name
Perm State Medical Academy
City
Perm
ZIP/Postal Code
614107
Country
Russian Federation
Facility Name
VA Baranov Respublical Hospital
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Rostov State Medical University
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
City Polyclinic No 20
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Facility Name
Imc Sogaz
City
St Petersburg
ZIP/Postal Code
191186
Country
Russian Federation
Facility Name
Medical Center Reavita
City
St Petersburg
ZIP/Postal Code
194295
Country
Russian Federation
Facility Name
City Hospital of the Holy Martyr Elizabeth
City
St Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
Nikolaev Hospital
City
St Petersburg
ZIP/Postal Code
198510
Country
Russian Federation
Facility Name
Bashkir State Medical University
City
Ufa
ZIP/Postal Code
450000
Country
Russian Federation
Facility Name
Central City Clinical Hospital
City
Ulyanovsk
ZIP/Postal Code
432057
Country
Russian Federation
Facility Name
State Medical University
City
Volgograd
ZIP/Postal Code
400131
Country
Russian Federation
Facility Name
Regional Clinical Hospital
City
Yaroslavl
ZIP/Postal Code
150000
Country
Russian Federation
Facility Name
NV Solovyov Clinical Emergency Hospital
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes

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12-Month Efficacy and Safety of Diepalrestat in Adults With Diabetic Peripheral Neuropathy, a DB, Placebo-Controlled Study

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