Diabetic Polyneuropathy Clinical Trial
This clinical trial is to determine an effective dosage and to study the safety of an investigational drug -lidorestat (IDD-676)- which is intended to stop or slow the progression of diabetic peripheral neuropathy.
Diabetic peripheral neuropathy is one of the most important and serious complications of
diabetes. It can cause pain and loss of sensation, loss of mobility and lead to chronic
wounds and amputations. Studies indicate 50% or more of people who have diabetes now have or
will have significant neuropathy.
Several currently marketed or investigational drugs are available to treat the painful
symptoms of diabetic peripheral neuropathy, but there are no approved drugs that have been
shown to prevent or slow the progression of the neuropathy itself.
The current clinical trial is an early phase II study designed to investigate the safety of
the investigational drug lidorestat (IDD-676) and to determine the effect of various dose
levels on important biochemical processes in the pathology of diabetic neuropathy.
Participants who enter and complete this study will, if the agent is successful, help in a
very important way to bring an effective treatment from research laboratories to widespread
availability for treatment. On the basis of the results of this study, large scale studies
will be undertaken to support application for product registration and distribution in the
U.S. and other countries throughout the world.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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