Overview

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.