Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy
- Conditions
- Diabetic Polyneuropathy
- Registration Number
- NCT00043797
- Lead Sponsor
- The Institute for Diabetes Discovery, LLC
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Toronto General Hospital, University Health Network
🇨🇦Toronto, Ontario, Canada
University of Texas, Southwest Medical Center
🇺🇸Dallas, Texas, United States
Marin Endocrinology Associates
🇺🇸Greenbrae, California, United States
Centre de Recherche
🇨🇦Laval, Quebec, Canada
Diabetes & Glandular Disease Clinic
🇺🇸San Antonio, Texas, United States
Hospital de L'Enfant-Jesus
🇨🇦Quebec City, Quebec, Canada
Scottsdale Medical Specialists
🇺🇸Scottsdale, Arizona, United States
Glendale Adventist Medical Center
🇺🇸Glendale, California, United States
Diabetes & Endocrine Associates
🇺🇸La Jolla, California, United States
University of Miami, Dept. of Diabetes, Endocrinology & Metabolism
🇺🇸Miami, Florida, United States
Brody School of Medicine, East Carolina University
🇺🇸Greenville, North Carolina, United States
Johns Hopkins University - School of Medicine
🇺🇸Baltimore, Maryland, United States
University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Radiant Research
🇺🇸Gainesville, Florida, United States