Treatment of Peripheral Neuropathy in Patients With Diabetes

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Ruboxistaurin

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.