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CompletedNCT00044421Updated Nov 6, 2007

Treatment of Peripheral Neuropathy in Patients With Diabetes

A Phase 3 interventional study of Ruboxistaurin mesylate in Diabetic Neuropathies and Diabetes Mellitus, sponsored by Eli Lilly and Company. Completed at 71 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-11-06.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Diabetic Neuropathies
  • Diabetes Mellitus
03

In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's enrollment of 400 is above the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
400 participants

Interventions

  • DrugRuboxistaurin mesylate
06

What researchers measure

Primary outcomes

  1. Reduction in the progression of DPN measured by composite score

Secondary outcomes

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

07

Study locations

71 sites
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    Mesa, Arizona, United States
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    Irvine, California, United States
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    Long Beach, California, United States
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    Los Angeles, California, United States
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    Tustin, California, United States
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    New Britain, Connecticut, United States
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    Norwalk, Connecticut, United States
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    Clearwater, Florida, United States
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    Plantation, Florida, United States
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    Weston, Florida, United States
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    Atlanta, Georgia, United States
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    Idaho Falls, Idaho, United States
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    North Chicago, Illinois, United States
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    Indianapolis, Indiana, United States
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    Baltimore, Maryland, United States
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    Boston, Massachusetts, United States
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    Minneapolis, Minnesota, United States
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    Columbia, Missouri, United States
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    Omaha, Nebraska, United States
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    Henderson, Nevada, United States
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    Medford, New Jersey, United States
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    Buffalo, New York, United States
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    New York, New York, United States
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    Columbia, South Carolina, United States
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    Dallas, Texas, United States
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    Houston, Texas, United States
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    San Antonio, Texas, United States
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    Burlington, Vermont, United States
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    Norfolk, Virginia, United States
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    Morgantown, West Virginia, United States
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    Camperdown, New South Wales, Australia
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    St. Leonards, New South Wales, Australia
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    Caulfield, Victoria, Australia
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    Clayton, Victoria, Australia
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    Edegem, Belgium
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    Huy, Belgium
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    Willebroeck, Belgium
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    Vancouver, British Columbia, Canada
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    Winnipeg, Manitoba, Canada
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    Halifax, Nova Scotia, Canada
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    Toronto, Ontario, Canada
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    Charlottetown, Prince Edward Island, Canada
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    Laval, Quebec, Canada
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    Zagreb, Croatia
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    Aarhus C, Denmark
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    Keila, Estonia
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    Tallinn, Estonia
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    Helsinki, Finland
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    Jyvaskyla, Finland
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    Oulu, Finland
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    Dresden, Germany
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    Dusseldorf, Germany
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    Mainz, Germany
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    Budapest, Hungary
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    Debrecen, Hungary
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    Gopalapuram, Chennai, India
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    Bangalore, Karnataka, India
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    Mumbai, Maharashtra, India
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    Chennai, Tamil Nadu, India
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    Kaunas, Lithuania
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    Klaipeda, Lithuania
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    Vilnus, Lithuania
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    Amersfoort, Netherlands
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    Santiago, La Coruna, Spain
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    Dos Hermanas, Sevilla, Spain
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    Madrid, Spain
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    Poole, Dorset, United Kingdom
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    Salford, Manchester, United Kingdom
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    Shrewsbury, Shropshire, United Kingdom
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    Sheffield, South Yorkshire, United Kingdom
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    Manchester, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00044421
Lead sponsor
Eli Lilly and Company
First posted
Aug 30, 2002
Start date
Jul 2002
Completion
Oct 2006
Last update
Nov 6, 2007

Study contacts

Call 1-877-CTLILLY (1977-285-4559) or 1317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company
View the source record on ClinicalTrials.gov ↗

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