Effect of LY333531 on Vascular and Neural Functions

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chromaderm, Inc.
• Collaborator: Joslin Diabetes Center
• Treatments: Ruboxistaurin

Criteria

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.