LY333531 Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes

Eli Lilly and Company1 site in 1 country200 target enrollmentJuly 2002

Overview

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 2005

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 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.

•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.

Reduction in neuropathic symptoms

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