Clinical trial NCT00043797: Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetic Polyneuropathy
Keywords: ARI
Diabetic polyneuropathy
Diabetic complications
Lead sponsor: The Institute for Diabetes Discovery, LLC
Sponsor class: INDUSTRY
First posted: 2002-08-15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Medical Specialists
state: Arizona
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Greenbrae
country: United States
facility: Marin Endocrinology Associates
state: California
city: La Jolla
country: United States
facility: Diabetes & Endocrine Associates
state: California
city: Gainesville
country: United States
facility: Radiant Research
state: Florida
city: Miami
country: United States
facility: University of Miami, Dept. of Diabetes, Endocrinology & Metabolism
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins University - School of Medicine
state: Maryland
city: Greenville
country: United States
facility: Brody School of Medicine, East Carolina University
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Dallas
country: United States
facility: University of Texas, Southwest Medical Center
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Clinic
state: Texas
city: Toronto
country: Canada
facility: Toronto General Hospital, University Health Network
state: Ontario
city: Laval
country: Canada
facility: Centre de Recherche
state: Quebec
city: Quebec City
country: Canada
facility: Hospital de L'Enfant-Jesus
state: Quebec
Study officials:
References: