Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes

This study has been completed.
Information provided by:
Eli Lilly and Company Identifier:
First received: August 28, 2002
Last updated: November 5, 2007
Last verified: November 2007
The purpose of this protocol is to determine if an investigational drug known as LY333531 is effective in treating nerve malfunction in diabetes.

Condition Intervention Phase
Diabetic Neuropathies
Diabetes Mellitus, Insulin-Dependent
Diabetes Mellitus, Non-Insulin-Dependent
Drug: Ruboxistaurin mesylate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: LY333531 Treatment of Symptomatic Peripheral Neuropathy in Patients With Diabetes

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Reduction in neuropathic symptoms

Secondary Outcome Measures:
  • Vibration sensation;Neurological signs;Electrophysiology of peroneal, tibial and sural nerves;Relief of symptoms as measured by VAS;Composite scores of nerve function;Clinical global impression of change

Estimated Enrollment: 200
Study Start Date: July 2002
Study Completion Date: October 2005

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00044408

  Show 35 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information: Identifier: NCT00044408     History of Changes
Other Study ID Numbers: 6204  B7A-MC-MBCW 
Study First Received: August 28, 2002
Last Updated: November 5, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetic Neuropathies
Peripheral Nervous System Diseases
Autoimmune Diseases
Diabetes Complications
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Nervous System Diseases
Neuromuscular Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 30, 2016