LY333531 Treatment of Peripheral Neuropathy in Patients With Diabetes

Eli Lilly and Company2 sites in 2 countries400 target enrollmentJuly 2002

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Diabetic Neuropathies
Sponsor: Eli Lilly and Company
Enrollment: 400
Locations: 2
Primary Endpoint: Reduction in the progression of DPN measured by composite score
Status: Completed
Last Updated: 18 years ago

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

Registry

clinicaltrials.gov

Start Date

July 2002

End Date

October 2006

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

•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.

•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.

Reduction in the progression of DPN measured by composite score

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