Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes

Eli Lilly and Company200 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Diabetic Neuropathies Diabetes Mellitus, Insulin-Dependent Diabetes Mellitus, Non-Insulin-Dependent

Interventions

Ruboxistaurin mesylateDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 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 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.

Locations (39)

Outcomes

Primary Outcomes

Reduction in neuropathic symptoms

Secondary Outcomes

Vibration sensation;Neurological signs;Electrophysiology of peroneal, tibial and sural nerves;Relief of symptoms as measured by VAS;Composite scores of nerve function;Clinical global impression of change

Data from ClinicalTrials.gov

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Mesa, Arizona, United States

Irvine, California, United States

Los Angeles, California, United States

Tustin, California, United States

New Britain, Connecticut, United States

Weston, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Omaha, Nebraska, United States

...and 29 more locations