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Greenbrae, California

  • Diabetic Polyneuropathy

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

676/US/2-01


NCT ID:

NCT00043797


Secondary ID:


Study Acronym:


Brief Title:

Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy


Official Title:


Overall Status:

Active, not recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The Institute for Diabetes Discovery, LLC


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Verification Date:December 2002
Last Changed Date:June 23, 2005
First Received Date:August 13, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Lidorestat (IDD 676)

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:The Institute for Diabetes Discovery, LLC

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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