Treatment of Peripheral Neuropathy in Patients With Diabetes

Phase 3

Completed

• Conditions: Diabetic Neuropathies; Diabetes Mellitus

• Registration Number: NCT00044421
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Study First Submitted: 2002-08-28
• Study First Submitted QC: 2002-08-29
• Study First Posted: 2002-08-30
• Study Completion: 2006-10
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-05
• Last Update Posted: 2007-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in the progression of DPN measured by composite score

Secondary Outcome Measures

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

Trial Locations

Locations (2)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇬🇧 Manchester, United Kingdom

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.; 🇪🇸 Dos Hermanas, Sevilla, Spain