Treatment for Symptomatic 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:	NCT00044395

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, Insulin-Dependent Diabetes Mellitus, Non-Insulin-Dependent	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 for Symptomatic Peripheral Neuropathy in Patients With Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1 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 neuropathic symptoms

Secondary Outcome Measures:

Vibration sensation;Neurological signs;Electrophysiology of peroneal, tibial and sural nerves;Relief of symptoms as measured by VAS;Composite scores of nerve function;Clinical global impression of change

Estimated Enrollment:	200
Study Start Date:	July 2002
Study Completion Date:	October 2005

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 clinically diagnosed positive sensory symptoms such as numbness, lancinating pain, burning pain, aching pain, allodynia and prickling sensation that have been present not greater than 5 years but stable for 6 months.
Has a 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 or currently participating in a Medical study in which you receive an experimental drug.
Are a woman and are pregnant or breastfeeding, intend to become pregnant within the next 2 years or a woman not using effective birth control.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044395

Show 39 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 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:	2133, B7A-MC-MBBP
Study First Received:	August 28, 2002
Last Updated:	November 5, 2007
ClinicalTrials.gov Identifier:	NCT00044395 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Autoimmune Diseases
Diabetic Neuropathies
Diabetes Mellitus
Endocrine System Diseases
Diabetes Mellitus Type 1
Diabetes Mellitus, Type 1
Neuromuscular Diseases

Ruboxistaurin
Peripheral Nervous System Diseases
Diabetes Mellitus, Type 2
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Diabetes Complications

Additional relevant MeSH terms:

Metabolic Diseases
Autoimmune Diseases
Molecular Mechanisms of Pharmacological Action
Diabetic Neuropathies
Immune System Diseases
Nervous System Diseases
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors

Pharmacologic Actions
Diabetes Mellitus, Type 1
Neuromuscular Diseases
Ruboxistaurin
Peripheral Nervous System Diseases
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Diabetes Complications

ClinicalTrials.gov processed this record on July 02, 2009