Treatment of Peripheral Neuropathy in Patients With Diabetes - Tabular View

Tracking Information

First Received Date ^ICMJE

August 28, 2002

Last Updated Date

November 5, 2007

Start Date ^ICMJE

July 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Reduction in the progression of DPN measured by composite score

Original Primary Outcome Measures ^ICMJE

- Reduction in the progression of DPN measured by composite score

Change History

Complete list of historical versions of study NCT00044421 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Vibration sensation;Electrophysiology of tibial, peroneal and sural nerves;Neurological signs;Neuropathic symptoms;Clinical global impression of change;Health outcome measures

Original Secondary Outcome Measures ^ICMJE

- Vibration sensation
- Electrophysiology of tibial, peroneal and sural nerves
- Neurological signs
- Neuropathic symptoms
- Clinical global impression of change
- Health outcome measures

Descriptive Information

Brief Title ^ICMJE

Treatment of Peripheral Neuropathy in Patients With Diabetes

Official Title ^ICMJE

LY333531 Treatment of Peripheral Neuropathy in Patients With Diabetes

Brief Summary

The purpose of this protocol is to determine if an investigational drug is effective in treating nerve malfunction in diabetes.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diabetic Neuropathies
Diabetes Mellitus

Intervention ^ICMJE

Drug: Ruboxistaurin mesylate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

400

Completion Date

October 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Belgium, Canada, Croatia, Denmark, Estonia, Finland, Germany, Hungary, India, Lithuania, Netherlands, Spain, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00044421

Responsible Party

Study ID Numbers ^ICMJE

2784, B7A-MC-MBBR

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Eli Lilly and Company

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP