Treatment of Peripheral Neuropathy in Patients With Diabetes

Lilly

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus

Diabetic Neuropathies

Treatments

Drug: Ruboxistaurin mesylate

Study type

Interventional

Funder types

Industry

Identifiers

B7A-MC-MBBR

2784

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.