Diabetic PolyneuropathyPhase 2NCT00043797
Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy
A Phase 2 study testing Lidorestat (IDD 676) in people with Diabetic Polyneuropathy, run by The Institute for Diabetes Discovery, LLC at 14 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Polyneuropathy
- What is being tested?
- Lidorestat (IDD 676)
- How many people
- Not given
- Where
- 14 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy or breast feeding
- Presence of uncontrolled hypertension
- History or presence of significant kidney or liver disease.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States11 sites
Johns Hopkins University - School of Medicine
Baltimore, Maryland, 21205
University of Texas, Southwest Medical Center
Dallas, Texas
Radiant Research
Gainesville, Florida, 32605
Glendale Adventist Medical Center
Glendale, California, 91206
Marin Endocrinology Associates
Greenbrae, California
Brody School of Medicine, East Carolina University
Greenville, North Carolina
Diabetes & Endocrine Associates
La Jolla, California, 92037
University of Miami, Dept. of Diabetes, Endocrinology & Metabolism
Miami, Florida, 33136
University of Oklahoma
Oklahoma City, Oklahoma
Diabetes & Glandular Disease Clinic
San Antonio, Texas
Scottsdale Medical Specialists
Scottsdale, Arizona
Canada3 sites
Centre de Recherche
Laval, Quebec
Hospital de L'Enfant-Jesus
Québec, Quebec
Toronto General Hospital, University Health Network
Toronto, Ontario
About this study
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.
Read the 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.
- Conditions
- Diabetic Polyneuropathy
- Being tested
- Lidorestat (IDD 676)
- Keywords
- ARI, Diabetic polyneuropathy, Diabetic complications
- Medical subject headings
- Diabetic Neuropathies, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidorestat (IDD 676)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2002 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PolyneuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- The Institute for Diabetes Discovery, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043797
- Sponsor's protocol ID
- 676/US/2-01
- Status last verified
- Dec 2002
- First submitted
- 13 Aug 2002
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT00043797
- Acronym / sponsor ID
- 676/US/2-01
- Conditions
- Diabetic Polyneuropathy
- Keywords
- ARI, Diabetic polyneuropathy, Diabetic complications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- The Institute for Diabetes Discovery, LLCIndustry (pharma, biotech, devices)
- First posted
- 15 Aug 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnancy or breast feeding
- Presence of uncontrolled hypertension
- History or presence of significant kidney or liver disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidorestat (IDD 676) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Click here for more information on diabetes and diabetic neuropathyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidorestat (IDD 676) in people with Diabetic Polyneuropathy, run by The Institute for Diabetes Discovery, LLC at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005; AzTrials last refreshed its copy on 7 Nov 2026.