Effect of LY333531 on Vascular and Neural Functions

The Effects of a Protein Kinase C Beta Inhibitor, LY333531, on Vascular and Neural Functions in Type 2 Diabetes Mellitus - Study B7A-MC-MBDM

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.

32mg Ruboxistaurin; 4 week cross-over treatment.

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.