Completed

Investigational Drug for Diabetic Peripheral Neuropathy

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study AimThis phase 3 study aims to evaluate the effectiveness of an investigational drug in reducing neuropathic symptoms in individuals with diabetic peripheral neuropathy.
What is being tested

Data Collection

Who is being recruted

Autoimmune Diseases
+10

+ Diabetes Mellitus
+ Diabetes Mellitus, Type 1
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: July 2002
See protocol details

Summary

Principal SponsorEli Lilly and Company
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2002Actual date on which the first participant was enrolled.

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

Official TitleLY333531 Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes 
NCT00044395
Principal SponsorEli Lilly and Company
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
200 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Autoimmune Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetic Neuropathies
Endocrine System Diseases
Immune System Diseases
Metabolic Diseases
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
Glucose Metabolism Disorders
Diabetes Complications
Criteria

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 39 locations
Suspended
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physicianMesa, United StatesSee the location
Suspended
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physicianIrvine, United States
Suspended
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physicianLos Angeles, United States
Suspended
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physicianTustin, United States
Completed39 Study Centers