12-Month Efficacy and Safety of Diepalrestat in Adults With Diabetic Peripheral Neuropathy, a DB, Placebo-Controlled Study
Status:
Completed
Trial end date:
2017-11-01
Target enrollment:
Participant gender:
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.