Effect of LY333531 on Vascular and Neural Functions

Phase 2

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT00482976
• Lead Sponsor: Chromaderm, Inc.

Brief Summary

To determine if protein kinase C beta plays a significant role in vascular endothelial dysfunction, small fiber neural dysfunction, and oxidative stress associated with diabetes mellitus.

Detailed Description

32mg Ruboxistaurin; 4 week cross-over treatment.

Study Timeline

• Study Start: 2003-12
• Study Completion: 2005-03
• Study First Submitted: 2007-06-04
• Study First Submitted QC: 2007-06-04
• Study First Posted: 2007-06-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Type 2 diabetes diagnosed for at least 1 mo and less than 10 yrs prior to visit 1
• HbA1c less than 9% and fasting plasma glucose less than 260mg/dl
• Blood pressure less than 160/100 mmHg
• Total cholesterol less than 300 mg/dl and/or triglycerides less than 600 mg/dl

Exclusion Criteria

• Subjects treated with a thiazolidinedione (TZD) in 12 weeks prior to visit 1.
• History of heart disease (MI, unstable angina, CVA, TIA, CABG, or percutaneous transluminal coronary angioplasty) w/in 6 months of visit 1 or subjects with BYHA class III or IV congestive heart failure.
• Female subjects of child-bearing potential that are pregnant or intend to become pregnant (i.e. not practicing an acceptable method of birth control)
• TSH greater than 1.5 times upper limit of normal at V1 or other endocrine disease.
• ALT greater than 1.5 times upper limit of normal at V1; Serum creatinine greater than 2.0mg/dl at V1; micro-albumin greater than 300.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Improvement in endothelium-dependent vasodilation of the microcirculation of the skin and nerve axon-related reflex vasodilation.	4 weeks
Improvement in endothelium-dependent vasodilation of the brachial artery (flow mediated dilation)	4 weeks
Improvement in selective measurements of oxidative stress, endothelial activity and vascular abnormalities which will correlate with PKC activity in the peripheral monocytes.	4 weeks

Secondary Outcome Measures

Name	Time	Method
Safety of ruboxistaurin	4 weeks

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇺🇸 Boston, Massachusetts, United States