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Treatment of Peripheral Neuropathy in Patients With Diabetes
This study has been completed.
Sponsored by: 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

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

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

  Show 71 Study Locations
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

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

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

Study placed in the following topic categories:
Metabolic Diseases
Neuromuscular Diseases
Diabetic Neuropathies
Ruboxistaurin
Peripheral Nervous System Diseases
Diabetes Mellitus
 Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Diabetes Complications

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009



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