Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2002 by The Institute for Diabetes Discovery, LLC.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
The Institute for Diabetes Discovery, LLC
ClinicalTrials.gov Identifier:
NCT00043797
First received: August 13, 2002
Last updated: June 23, 2005
Last verified: December 2002
  Purpose

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 Intervention Phase
Diabetic Polyneuropathy
Drug: Lidorestat (IDD 676)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by The Institute for Diabetes Discovery, LLC:

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043797

Locations
United States, Arizona
Scottsdale Medical Specialists
Scottsdale, Arizona, United States
United States, California
Glendale Adventist Medical Center
Glendale, California, United States, 91206
Marin Endocrinology Associates
Greenbrae, California, United States
Diabetes & Endocrine Associates
La Jolla, California, United States, 92037
United States, Florida
Radiant Research
Gainesville, Florida, United States, 32605
University of Miami, Dept. of Diabetes, Endocrinology & Metabolism
Miami, Florida, United States, 33136
United States, Maryland
Johns Hopkins University - School of Medicine
Baltimore, Maryland, United States, 21205
United States, North Carolina
Brody School of Medicine, East Carolina University
Greenville, North Carolina, United States
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States
United States, Texas
University of Texas, Southwest Medical Center
Dallas, Texas, United States
Diabetes & Glandular Disease Clinic
San Antonio, 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
Sponsors and Collaborators
The Institute for Diabetes Discovery, LLC
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00043797     History of Changes
Other Study ID Numbers: 676/US/2-01
Study First Received: August 13, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by The Institute for Diabetes Discovery, LLC:
ARI
Diabetic polyneuropathy
Diabetic complications

Additional relevant MeSH terms:
Diabetic Neuropathies
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 20, 2014