Treatment of Peripheral Neuropathy in Patients With Diabetes

Eli Lilly and Company400 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

400

Conditions

Diabetic Neuropathies Diabetes Mellitus

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 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.

Locations (71)

Outcomes

Primary Outcomes

Reduction in the progression of DPN measured by composite score

Secondary Outcomes

Vibration sensation;Electrophysiology of tibial, peroneal and sural nerves;Neurological signs;Neuropathic symptoms;Clinical global impression of change;Health outcome measures

Data from ClinicalTrials.gov

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Mesa, Arizona, United States

Irvine, California, United States

Long Beach, California, United States

Los Angeles, California, United States

Tustin, California, United States

New Britain, Connecticut, United States

Norwalk, Connecticut, United States

Clearwater, Florida, United States

Plantation, Florida, United States

Weston, Florida, United States

...and 61 more locations