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Treatment of Peripheral Neuropathy in Patients With Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00044421
First Posted: August 30, 2002
Last Update Posted: November 6, 2007
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.
Information provided by:
Eli Lilly and Company
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: LY333531 Treatment of Peripheral Neuropathy in Patients With Diabetes

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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


  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

Additional Information:
ClinicalTrials.gov Identifier: NCT00044421     History of Changes
Other Study ID Numbers: 2784
B7A-MC-MBBR
First Submitted: August 28, 2002
First Posted: August 30, 2002
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