Treatment of Peripheral Neuropathy in Patients With Diabetes - Full Text View

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

ChemIDplus related topics:

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
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 September 05, 2008