Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy

Tracking Information
First Submitted Date ICMJE	August 13, 2002
First Posted Date ICMJE	August 15, 2002
Last Update Posted Date	June 24, 2005
Study Start Date ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy
Official Title ICMJE	Not Provided
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 Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
Condition ICMJE	Diabetic Polyneuropathy
Intervention ICMJE	Drug: Lidorestat (IDD 676)
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Enrollment ICMJE	Not Provided
Original Enrollment ICMJE	Not Provided
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 70 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Canada, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00043797
Other Study ID Numbers ICMJE	676/US/2-01
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	The Institute for Diabetes Discovery, LLC
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	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