Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy

June 23, 2005 updated by: The Institute for Diabetes Discovery, LLC
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Institute for Diabetes Discovery, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 13, 2002

First Submitted That Met QC Criteria

August 14, 2002

First Posted (Estimate)

August 15, 2002

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

December 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 676/US/2-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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