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Treatment of Peripheral Neuropathy in Patients With Diabetes
This study has been completed.
First Received: August 28, 2002   Last Updated: November 5, 2007   History of Changes
Sponsor: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00044421
  Purpose

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


Condition Intervention Phase
Diabetic Neuropathies
Diabetes Mellitus
 Drug: Ruboxistaurin mesylate
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: LY333531 Treatment of Peripheral Neuropathy in Patients With Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetic Nerve Problems Peripheral Nerve Disorders
Drug Information available for: Ruboxistaurin
U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Reduction in the progression of DPN measured by composite score

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

Estimated Enrollment: 400
Study Start Date: July 2002
Study Completion Date: October 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00044421

  Hide Study Locations
Locations
United States, Arizona
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Mesa, Arizona, United States
United States, California
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Los Angeles, California, United States
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Tustin, California, United States
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Irvine, California, United States
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Long Beach, California, United States
United States, Connecticut
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New Britain, Connecticut, United States
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Norwalk, Connecticut, United States
United States, Florida
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Weston, Florida, United States
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Clearwater, Florida, United States
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Plantation, Florida, United States
United States, Georgia
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Atlanta, Georgia, United States
United States, Idaho
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Idaho Falls, Idaho, United States
United States, Illinois
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North Chicago, Illinois, United States
United States, Indiana
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Indianapolis, Indiana, United States
United States, Maryland
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Baltimore, Maryland, United States
United States, Massachusetts
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Boston, Massachusetts, United States
United States, Minnesota
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Minneapolis, Minnesota, United States
United States, Missouri
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Columbia, Missouri, United States
United States, Nebraska
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Omaha, Nebraska, United States
United States, Nevada
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Henderson, Nevada, United States
United States, New Jersey
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Medford, New Jersey, United States
United States, New York
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Buffalo, New York, United States
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New York, New York, United States
United States, South Carolina
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Columbia, South Carolina, United States
United States, Texas
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Houston, Texas, United States
United States, Vermont
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Burlington, Vermont, United States
United States, Virginia
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Norfolk, Virginia, United States
United States, West Virginia
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Morgantown, West Virginia, United States
Australia, New South Wales
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St. Leonards, New South Wales, Australia
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Camperdown, New South Wales, Australia
Australia, Victoria
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Caulfield, Victoria, Australia
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Clayton, Victoria, Australia
Belgium
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Huy, Belgium
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Edegem, Belgium
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Willebroeck, Belgium
Canada, British Columbia
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Vancouver, British Columbia, Canada
Canada, Manitoba
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Winnipeg, Manitoba, Canada
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada
Canada, Ontario
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Toronto, Ontario, Canada
Canada, Prince Edward Island
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Charlottetown, Prince Edward Island, Canada
Canada, Quebec
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Laval, Quebec, Canada
Croatia
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Zagreb, Croatia
Denmark
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Aarhus C, Denmark
Estonia
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Keila, Estonia
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Tallinn, Estonia
Finland
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Helsinki, Finland
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Oulu, Finland
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Jyvaskyla, Finland
Germany
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Mainz, Germany
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Dusseldorf, Germany
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Dresden, Germany
Hungary
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Debrecen, Hungary
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Budapest, Hungary
India, Chennai
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Gopalapuram, Chennai, India
India, Karnataka
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Bangalore, Karnataka, India
India, Maharashtra
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Mumbai, Maharashtra, India
India, Tamil Nadu
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Chennai, Tamil Nadu, India
Lithuania
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Kaunas, Lithuania
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Klaipeda, Lithuania
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Vilnus, Lithuania
Netherlands
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Amersfoort, Netherlands
Spain
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Madrid, Spain
Spain, La Coruna
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Santiago, La Coruna, Spain
Spain, Sevilla
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Dos Hermanas, Sevilla, Spain
United Kingdom
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Manchester, United Kingdom
United Kingdom, Dorset
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Poole, Dorset, United Kingdom
United Kingdom, Manchester
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Salford, Manchester, United Kingdom
United Kingdom, Shropshire
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Shrewsbury, Shropshire, United Kingdom
United Kingdom, South Yorkshire
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Sheffield, South Yorkshire, United Kingdom
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1977-285-4559) or 1317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: 2784, B7A-MC-MBBR
Study First Received: August 28, 2002
Last Updated: November 5, 2007
ClinicalTrials.gov Identifier: NCT00044421     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Metabolic Diseases
Diabetic Neuropathies
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
 Pharmacologic Actions
Neuromuscular Diseases
Peripheral Nervous System Diseases
Ruboxistaurin
Glucose Metabolism Disorders
Diabetes Complications

ClinicalTrials.gov processed this record on November 27, 2009



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