Diabetic NeuropathiesPhase 3NCT00044421

Treatment of Peripheral Neuropathy in Patients With Diabetes

A Phase 3 study testing Ruboxistaurin mesylate in people with Diabetic Neuropathies and Diabetes Mellitus, run by Eli Lilly and Company at 71 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this protocol is to determine if an investigational drug is effective in treating nerve malfunction in diabetes. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Neuropathies, Diabetes Mellitus
What is being tested?: Ruboxistaurin mesylate
How many people: 400 participants
Where: 71 sitesin 15 countries
Study dates: Jul 2002to Oct 2006
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must have type I or type II Diabetes Mellitus.
Have been clinically diagnosed with neuropathy.
Have an HbA1C less than or equal to 12%. Patients with HbA1C greater than 9% must be on insulin therapy.
Must be 18 years or older.
Be able to visit the doctor's office approximately 3 times over a maximum of a 6-week period to determine if you can continue in the study.

Who cannot join

History of significant liver problems.
Have poor kidney function.
Drink an excess of alcohol or abuse drugs.
Have recently participated in or are currently participating in a Medical study in which you receive an experimental drug.
Are a woman and are pregnant or breastfeeding, intending to become pregnant within the next 2 years, or are a woman not using an effective method of birth control.

Trial locations and contacts

71 sites in 15 countries.

Country

City, postcode or hospital

71 sites in 15 countries

United States30 sites

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Atlanta, Georgia
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Baltimore, Maryland
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Boston, Massachusetts
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Buffalo, New York
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Burlington, Vermont
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Clearwater, Florida
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Columbia, Missouri
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Columbia, South Carolina
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Dallas, Texas
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Henderson, Nevada
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Houston, Texas
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Idaho Falls, Idaho
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Indianapolis, Indiana
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Irvine, California
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Long Beach, California
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Los Angeles, California
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Medford, New Jersey
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Mesa, Arizona
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Minneapolis, Minnesota
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Morgantown, West Virginia
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New Britain, Connecticut
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New York, New York
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Norfolk, Virginia
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North Chicago, Illinois
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Norwalk, Connecticut
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Omaha, Nebraska
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Plantation, Florida
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San Antonio, Texas
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Tustin, California
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Weston, Florida

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Canada6 sites

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Charlottetown, Prince Edward Island
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Halifax, Nova Scotia
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Laval, Quebec
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Toronto, Ontario
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Vancouver, British Columbia
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Winnipeg, Manitoba

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United Kingdom5 sites

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Manchester
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Poole, Dorset
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Salford, Manchester
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Sheffield, South Yorkshire
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Shrewsbury, Shropshire

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Australia4 sites

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Camperdown, New South Wales
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Caulfield, Victoria
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Clayton, Victoria
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St Leonards, New South Wales

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India4 sites

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Bangalore, Karnataka
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Chennai, Tamil Nadu
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Gopālapuram, Chennai
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Mumbai, Maharashtra

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Belgium3 sites

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Edegem
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Huy
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Willebroek

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Finland3 sites

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Helsinki
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Jyväskylä
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Oulu

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Germany3 sites

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Dresden
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Düsseldorf
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Mainz

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Lithuania3 sites

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Kaunas
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Klaipėda
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Vilnius

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Spain3 sites

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Dos Hermanas, Sevilla
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Madrid
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Santiago, La Coruna

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Estonia2 sites

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Keila
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Tallinn

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Hungary2 sites

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Budapest
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Debrecen

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Croatia1 site

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Zagreb

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Denmark1 site

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Aarhus C

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Netherlands1 site

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Amersfoort

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About this study

Official title: LY333531 Treatment of Peripheral Neuropathy in Patients With Diabetes

The purpose of this protocol is to determine if an investigational drug is effective in treating nerve malfunction in diabetes.

Conditions: Diabetic Neuropathies, Diabetes Mellitus
Being tested: Ruboxistaurin mesylate
Medical subject headings: Diabetic Neuropathies, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ruboxistaurin mesylateDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

Reduction in the progression of DPN measured by composite score

Secondary outcomes (1)

Vibration sensation;Electrophysiology of tibial, peroneal and sural nerves;Neurological signs;Neuropathic symptoms;Clinical global impression of change;Health outcome measures

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2002Oct 2006

First posted30 Aug 2002 (estimated)
Study startJul 2002
Study completionOct 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 400 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00044421
Sponsor's protocol ID: 2784
Other IDs: B7A-MC-MBBR
Status last verified: Nov 2007
First submitted: 28 Aug 2002
Last updated: 6 Nov 2007
Results posted: No

Publications

Hu S, Lee K, He JC, Fan Y. Current Landscape and Emerging Therapeutic Targets in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Mar 10. doi: 10.2215/CJN.0000001053. Online ahead of print.
PubMed 41805697

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Not yet recruiting
Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)

All Diabetic Neuropathies trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: LY333531 Treatment of Peripheral Neuropathy in Patients With Diabetes
ClinicalTrials.gov ID: NCT00044421
Acronym / sponsor ID: 2784
Conditions: Diabetic Neuropathies, Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 400 participants
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jul 2002
Study completion: Oct 2006 (actual)
First posted: 30 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.

The purpose of this protocol is to determine if an investigational drug is effective in treating nerve malfunction in diabetes.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients must have type I or type II Diabetes Mellitus.
Have been clinically diagnosed with neuropathy.
Have an HbA1C less than or equal to 12%. Patients with HbA1C greater than 9% must be on insulin therapy.
Must be 18 years or older.
Be able to visit the doctor's office approximately 3 times over a maximum of a 6-week period to determine if you can continue in the study.

Key exclusion criteria (5 listed)

History of significant liver problems.
Have poor kidney function.
Drink an excess of alcohol or abuse drugs.
Have recently participated in or are currently participating in a Medical study in which you receive an experimental drug.
Are a woman and are pregnant or breastfeeding, intending to become pregnant within the next 2 years, or are a woman not using an effective method of birth control.

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
Ruboxistaurin mesylate	Drug	–

Primary outcome

Reduction in the progression of DPN measured by composite score

1 secondary outcome

Vibration sensation;Electrophysiology of tibial, peroneal and sural nerves;Neurological signs;Neuropathic symptoms;Clinical global impression of change;Health outcome measures

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2007.
Derived from this study: PubMed 41805697Hu S, Lee K, He JC, Fan Y. Current Landscape and Emerging Therapeutic Targets in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Mar 10. doi: 10.2215/CJN.0000001053. Online ahead of print.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Diabetic Neuropathies

Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Not yet recruiting
Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)

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.

Call 1-877-CTLILLY (1977-285-4559) or 1317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

71 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ruboxistaurin mesylate in people with Diabetic Neuropathies and Diabetes Mellitus, run by Eli Lilly and Company at 71 sites in 15 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 6 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Canada, United Kingdom, Australia, India and 10 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

What does the primary outcome measure?

Reduction in the progression of DPN measured by composite score. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00044421, which also lists 1 linked publication.

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 6 Nov 2007; AzTrials last refreshed its copy on 8 Nov 2026.