Effect of LY333531 on Vascular and Neural Functions
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 7/27/2016 |
| Start Date: | December 2003 |
| End Date: | March 2005 |
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.
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.
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