Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy - Tabular View

Tracking Information
First Received Date ^ICMJE	August 13, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00043797 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy
Official Title ^ICMJE
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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Diabetic Polyneuropathy
Intervention ^ICMJE	Drug: Lidorestat (IDD 676)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT ID ^ICMJE	NCT00043797
Responsible Party
Study ID Numbers ^ICMJE	676/US/2-01
Study Sponsor ^ICMJE	The Institute for Diabetes Discovery, LLC
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	The Institute for Diabetes Discovery, LLC
Verification Date	December 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP