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Treatment of Peripheral Neuropathy in Patients With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00044421
Recruitment Status : Completed
First Posted : August 30, 2002
Last Update Posted : November 6, 2007
Sponsor:
Information provided by:
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Diabetic Neuropathies Diabetes Mellitus Drug: Ruboxistaurin mesylate Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: LY333531 Treatment of Peripheral Neuropathy in Patients With Diabetes
Study Start Date : July 2002
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine





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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044421


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Locations
United States, Arizona
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Mesa, Arizona, United States
United States, California
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Irvine, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Tustin, 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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Clearwater, Florida, United States
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Plantation, Florida, United States
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Weston, 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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Houston, Texas, United States
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San Antonio, 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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Camperdown, New South Wales, Australia
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St. Leonards, 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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Edegem, Belgium
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Huy, 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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Jyvaskyla, Finland
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Oulu, Finland
Germany
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Dresden, Germany
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Dusseldorf, Germany
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Mainz, Germany
Hungary
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Budapest, Hungary
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Debrecen, Hungary
India
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Gopalapuram, Chennai, India
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Bangalore, Karnataka, India
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Mumbai, Maharashtra, India
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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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Santiago, La Coruna, Spain
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Dos Hermanas, Sevilla, Spain
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Madrid, Spain
United Kingdom
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Poole, Dorset, United Kingdom
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Salford, Manchester, United Kingdom
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Shrewsbury, Shropshire, United Kingdom
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Sheffield, South Yorkshire, United Kingdom
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Manchester, 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00044421     History of Changes
Other Study ID Numbers: 2784
B7A-MC-MBBR
First Posted: August 30, 2002    Key Record Dates
Last Update Posted: November 6, 2007
Last Verified: November 2007

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