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

NCT02332005 | Completed Phase 2

• 1 other identifier: NM-ARI-231
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 27

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.

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• change from baseline in peroneal motor nerve conduction velocity

  12 months

Secondary Outcomes (7)

• change from baseline in patient-reported Visual Acuity Scales

  12 months

• change from baseline in patient-reported responses to Toronto Clinical Neuropathy Score (TCNS)

  12 months

• change from baseline in quality of life administered by SF-36 instrument

  12 months

• change from baseline in median conduction velocity measurements

  12 months

• change in visual acuity compared to baseline

  12 months

Study Arms (3)

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

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

Drug: diepalrestat choline

Group 3

PLACEBO COMPARATOR

Tablet administered twice daily morning and evening containing placebo

Drug: Placebo

Interventions

diepalrestat choline DRUG

aldose reductase inhibitor

Also known as: BNV-222

Group 1 150 mg; Group 2 300 mg

Placebo DRUG

Placebo

Group 3

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NeuromaxBionevia: lead

Study Sites (27)

City Hospital No 40 of the Kurortny District

Saint Petersburg, Sestroretsk, 197706, Russia

Location

Northern State Medical University

Arkhangelsk, 163000, Russia

Location

Health Services Severstal

Cherepovets, 162600, Russia

Location

Kemerovo Regional Clinical Hospital

Kemerovo, 650066, Russia

Location

Endocrinology Dispensary

Moscow, 119034, Russia

Location

Morozovskaya Children City Hospital of Moscow

Moscow, 119049, Russia

Location

I M Sechenov First Moscow State Medical University

Moscow, 119435, Russia

Location

IM Sechenov First Moscow State Medical University

Moscow, 119435, Russia

Location

IM Sechenov First Moscow State Medical University

Moscow, 119991, Russia

Location

City Clinical Hospital No 71

Moscow, 121374, Russia

Location

Central Clinical Hospital No 1 of JSC Russian Railway

Moscow, 125367, Russia

Location

City Clinical Hospital No 50

Moscow, 127206, Russia

Location

The Federal Bureau of Medical and Social Expertise

Moscow, 127486, Russia

Location

Perm State Medical Academy

Perm, 614107, Russia

Location

VA Baranov Respublical Hospital

Petrozavodsk, 185019, Russia

Location

Rostov State Medical University

Rostov-on-Don, 344022, Russia

Location

Imc Sogaz

Saint Petersburg, 191186, Russia

Location

Medical Center Reavita

Saint Petersburg, 194295, Russia

Location

City Hospital of the Holy Martyr Elizabeth

Saint Petersburg, 195257, Russia

Location

Nikolaev Hospital

Saint Petersburg, 198510, Russia

Location

City Polyclinic No 20

Saratov, 410053, Russia

Location

Bashkir State Medical University

Ufa, 450000, Russia

Location

Central City Clinical Hospital

Ulyanovsk, 432057, Russia

Location

State Medical University

Volgograd, 400131, Russia

Location

Regional Clinical Hospital

Yaroslavl, 150000, Russia

Location

NV Solovyov Clinical Emergency Hospital

Yaroslavl, 150003, Russia

Location

Clinic of Neurology

Yekaterinburg, 620014, Russia

Location

Study Officials

• Julia Mockot, MD

  NeuroMax Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2015
• First Posted: January 6, 2015
• Study Start: November 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: September 27, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share

Locations

RU (27)