Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes



Status:Completed
Conditions:Diabetic Neuropathy, Neurology, Diabetes, Diabetes, Diabetes
Therapuetic Areas:Endocrinology, Neurology
Healthy:No
Age Range:18 - Any
Updated:7/27/2016
Start Date:July 2002
End Date:October 2005

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LY333531 Treatment of Symptomatic Peripheral Neuropathy in Patients With Diabetes

The purpose of this protocol is to determine if an investigational drug known as LY333531 is
effective in treating nerve malfunction in diabetes.


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.
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