Treatment of Peripheral Neuropathy in Patients With Diabetes

NCT00044421 | Completed Phase 3

• 2 other identifiers: 2784B7A-MC-MBBR
• Study Type: interventional
• Target: 400
• Locations: 14 countries
• Sites: 69

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Ruboxistaurin mesylate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (71)

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Mesa, Arizona, United States

Location

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Irvine, California, United States

Location

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Long Beach, California, United States

Location

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Los Angeles, California, United States

Location

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Tustin, California, United States

Location

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New Britain, Connecticut, United States

Location

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Norwalk, Connecticut, United States

Location

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Clearwater, Florida, United States

Location

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Plantation, Florida, United States

Location

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Weston, Florida, United States

Location

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Atlanta, Georgia, United States

Location

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Idaho Falls, Idaho, United States

Location

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North Chicago, Illinois, United States

Location

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Indianapolis, Indiana, United States

Location

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Baltimore, Maryland, United States

Location

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Boston, Massachusetts, United States

Location

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Minneapolis, Minnesota, United States

Location

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Columbia, Missouri, United States

Location

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Omaha, Nebraska, United States

Location

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Henderson, Nevada, United States

Location

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Medford, New Jersey, United States

Location

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Buffalo, New York, United States

Location

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New York, New York, United States

Location

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Columbia, South Carolina, United States

Location

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Dallas, Texas, United States

Location

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Houston, Texas, United States

Location

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San Antonio, Texas, United States

Location

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Burlington, Vermont, United States

Location

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Norfolk, Virginia, United States

Location

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Morgantown, West Virginia, United States

Location

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Camperdown, New South Wales, Australia

Location

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St Leonards, New South Wales, Australia

Location

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Caulfield, Victoria, Australia

Location

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Clayton, Victoria, Australia

Location

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Edegem, Belgium

Location

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Huy, Belgium

Location

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Willebroek, Belgium

Location

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Vancouver, British Columbia, Canada

Location

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Winnipeg, Manitoba, Canada

Location

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Halifax, Nova Scotia, Canada

Location

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Toronto, Ontario, Canada

Location

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Charlottetown, Prince Edward Island, Canada

Location

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Laval, Quebec, Canada

Location

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Zagreb, Croatia

Location

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Aarhus C, Denmark

Location

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Keila, Estonia

Location

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Tallinn, Estonia

Location

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Helsinki, Finland

Location

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Jyväskylä, Finland

Location

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Oulu, Finland

Location

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Dresden, Germany

Location

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Düsseldorf, Germany

Location

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Mainz, Germany

Location

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Budapest, Hungary

Location

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Debrecen, Hungary

Location

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Gopālapuram, Chennai, India

Location

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Bangalore, Karnataka, India

Location

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Mumbai, Maharashtra, India

Location

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Chennai, Tamil Nadu, India

Location

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Kaunas, Lithuania

Location

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Klaipėda, Lithuania

Location

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Vilnius, Lithuania

Location

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Amersfoort, Netherlands

Location

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Santiago, La Coruna, Spain

Location

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Dos Hermanas, Sevilla, Spain

Location

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Madrid, Spain

Location

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Poole, Dorset, United Kingdom

Location

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Salford, Manchester, United Kingdom

Location

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Shrewsbury, Shropshire, United Kingdom

Location

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Sheffield, South Yorkshire, United Kingdom

Location

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Manchester, United Kingdom

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 28, 2002
• First Posted: August 30, 2002
• Study Start: July 1, 2002
• Study Completion: October 1, 2006
• Last Updated: November 6, 2007

Record last verified: 2007-11

Locations

CR (1); ES (3); BE (3); CA (6); FI (3); LI (3); AU (4); GB (5); HU (2); NL (1); DK (1); DE (3); IN (4); US (30)