Completed

Investigational Drug for Diabetic Peripheral Neuropathy

Study Aim

This 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+11

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 1

Over 18 Years

+10 Eligibility Criteria

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: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2002

Actual 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: January 27, 2026

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 enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDiabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetic NeuropathiesEndocrine System DiseasesImmune System DiseasesMetabolic DiseasesNervous System DiseasesNeuromuscular DiseasesNutritional and Metabolic DiseasesPeripheral Nervous System DiseasesGlucose Metabolism DisordersDiabetes Complications

Criteria

5 inclusion criteria required to participate

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.

Show More Criteria

5 exclusion criteria prevent from participating

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.

Show More Criteria

Study Plan

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

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 physician

Mesa, United StatesOpen 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 physician in Google Maps

Suspended

Irvine, United States

Suspended

Los Angeles, United States

Suspended

Tustin, United States

Completed39 Study Centers