The Effect of Ruboxistaurin on Small Fiber Function

The Effect of Ruboxistaurin Mesylate (LY333531) on Small Fiber Function as Measured by Microvascular Skin Blood Flow, C-Fiber Quantitations in Skin and Quantitative Sensory Testing of Cold and Heat.

To determine the effect of Ruboxistaurin on small fiber function.

Study Overview

• Status: Completed
• Conditions: Diabetic Neuropathy
• Intervention / Treatment: Drug: Ruboxistaurin

• Study Type: Interventional
• Enrollment: 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients must have Type 1 or Type 2 diabetes mellitus
• Patients must have bilateral sensorimotor distal peripheral neuropathy attributable to diabetes mellitus
• Patients must have blood glucose control measured as HbA1c=<11%
• Patients must be 18 years of age or older.
• Patients must be able to return to all follow-up visits

Exclusion Criteria:

• Patients must not have symptoms of diabetic peripheral neuropathy that cannot be distinguished from other etiologies
• Patients must not have a neurologic disease or neuropathy from a cause other than diabetes mellitus that would interfere with correct evaluation of symptomatic peripheral neuropathy.
• Patient currently has uncontrolled high blood pressure
• You have other medical problems that your doctor feels would make it unsafe for you to participate in this study such as liver or kidney problems
• You are a woman of childbearing age and unwilling or unable to use effective contraceptive.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The objectives of this study is to evaluate the effect of ruboxistaurin on subjects with diabetic peripheral polyneuropathy

Secondary Outcome Measures

Outcome Measure
Ruboxistaurin will improve quantitative sensory testing and increase nerve fiber density in subjects with diabetic peripheral polyneuropathy.

Collaborators and Investigators

• Sponsor: Chromaderm, Inc.

Publications and helpful links

General Publications

• Casellini CM, Barlow PM, Rice AL, Casey M, Simmons K, Pittenger G, Bastyr EJ 3rd, Wolka AM, Vinik AI. A 6-month, randomized, double-masked, placebo-controlled study evaluating the effects of the protein kinase C-beta inhibitor ruboxistaurin on skin microvascular blood flow and other measures of diabetic peripheral neuropathy. Diabetes Care. 2007 Apr;30(4):896-902. doi: 10.2337/dc06-1699.

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Study Completion: November 1, 2005

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Estimate): July 26, 2016
• Last Update Submitted That Met QC Criteria: July 25, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Ruboxistaurin
• Other Study ID Numbers: 7550; B7A-MC-MBDO