Effect of LY333531 on Vascular and Neural Functions

Chromaderm

Status and phase

Completed

Phase 2

Conditions

Diabetes Mellitus

Treatments

Drug: Ruboxistaurin

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00482976

7546

B7A-MC-MBDM

Details and patient eligibility

About

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.

Full description

32mg Ruboxistaurin; 4 week cross-over treatment.

Enrollment

30 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.