Overview

This trial is active, not recruiting.

Condition diabetic polyneuropathy
Treatment lidorestat (idd 676)
Phase phase 2
Sponsor The Institute for Diabetes Discovery, LLC
Trial identifier NCT00043797, 676/US/2-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by The Institute for Diabetes Discovery, LLC.