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

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

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

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:

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

Study placed in the following topic categories:

Metabolic Diseases
Neuromuscular Diseases
Diabetic Neuropathies
Ruboxistaurin
Peripheral Nervous System Diseases
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Diabetes Complications

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 July 02, 2009