Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes

Chromaderm

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Non-Insulin-Dependent

Diabetic Neuropathies

Diabetes Mellitus, Insulin-Dependent

Treatments

Drug: Ruboxistaurin mesylate

Study type

Interventional

Funder types

Industry

Identifiers

6204

B7A-MC-MBCW

Details and patient eligibility

About

The purpose of this protocol is to determine if an investigational drug known as LY333531 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 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 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 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.