Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy
This trial is active, not recruiting.
|Treatment||lidorestat (idd 676)|
|Sponsor||The Institute for Diabetes Discovery, LLC|
|Trial identifier||NCT00043797, 676/US/2-01|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Scottsdale, AZ||Scottsdale Medical Specialists||no longer recruiting|
|Glendale, CA||Glendale Adventist Medical Center||no longer recruiting|
|Greenbrae, CA||Marin Endocrinology Associates||no longer recruiting|
|La Jolla, CA||Diabetes & Endocrine Associates||no longer recruiting|
|Gainesville, FL||Radiant Research||no longer recruiting|
|Miami, FL||University of Miami, Dept. of Diabetes, Endocrinology & Metabolism||no longer recruiting|
|Baltimore, MD||Johns Hopkins University - School of Medicine||no longer recruiting|
|Greenville, NC||Brody School of Medicine, East Carolina University||no longer recruiting|
|Oklahoma City, OK||University of Oklahoma||no longer recruiting|
|Dallas, TX||University of Texas, Southwest Medical Center||no longer recruiting|
|San Antonio, TX||Diabetes & Glandular Disease Clinic||no longer recruiting|
|Toronto, Canada||Toronto General Hospital, University Health Network||no longer recruiting|
|Laval, Canada||Centre de Recherche||no longer recruiting|
|Quebec City, Canada||Hospital de L'Enfant-Jesus||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Male or female participants from 18 years up to 70 years old.
Inclusion: - Clinical diagnosis of Type 1 or Type II diabetes with mild to moderate diabetic peripheral neuropathy. - Healthy status except for diabetes - Ability to make frequent clinic visits over a 7-month period. - Willingness and ability to understand and sign consent form. Exclusion: - Pregnancy or breast feeding - Presence of uncontrolled hypertension - History or presence of significant kidney or liver disease.
|Description||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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