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.

Condition	Treatment or Intervention	Phase
Diabetic Polyneuropathy	Drug: Lidorestat (IDD 676)	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

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.

Arizona
      Scottsdale Medical Specialists, Scottsdale,  Arizona,  United States
California
      Marin Endocrinology Associates, Greenbrae,  California,  United States
      Diabetes & Endocrine Associates, La Jolla,  California,  92037,  United States
      Glendale Adventist Medical Center, Glendale,  California,  91206,  United States
Florida
      University of Miami, Dept. of Diabetes, Endocrinology & Metabolism, Miami,  Florida,  33136,  United States
      Radiant Research, Gainesville,  Florida,  32605,  United States
Maryland
      Johns Hopkins University - School of Medicine, Baltimore,  Maryland,  21205,  United States
North Carolina
      Brody School of Medicine, East Carolina University, Greenville,  North Carolina,  United States
Oklahoma
      University of Oklahoma, Oklahoma City,  Oklahoma,  United States
Texas
      Diabetes & Glandular Disease Clinic, San Antonio,  Texas,  United States
      University of Texas, Southwest Medical Center, Dallas,  Texas,  United States
Canada, Ontario
      Toronto General Hospital, University Health Network, Toronto,  Ontario,  Canada
Canada, Quebec
      Centre de Recherche, Laval,  Quebec,  Canada
      Hospital de L'Enfant-Jesus, Quebec City,  Quebec,  Canada

Study ID Numbers:  676/US/2-01
Record last reviewed:  December 2002
Last Updated:  October 13, 2004
Record first received:  August 13, 2002
ClinicalTrials.gov Identifier:  NCT00043797
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08