The purpose of this study is to determine whether ruboxistaurin can reduce blood vessel
inflammation associated with diabetes.
1. Type 2 diabetes mellitus
2. ≥35 years of age
3. Fasting low-density lipoprotein (LDL) cholesterol <160 mg/dL, triglycerides (TG) <400
4. Sitting systolic blood pressure <160 mm Hg and sitting diastolic blood pressure <90
mm Hg as determined by the mean of three separate measurements.
5. Hemoglobin A1c (HbA1c) ≥7% and ≤11%.
6. A serum creatinine >2.0 mg/dL or who have received a renal transplant or are
currently being treated with dialysis.
7. Alanine aminotransaminase (ALT), alkaline phosphatase (ALP), or total bilirubin (TB)
greater than two times the upper limit of normal
8. Current use of aspirin, nitroglycerin or long-acting nitrates or potential need for
use of aspirin, nitroglycerin or long-acting nitrates to treat documented
cerebrovascular or coronary artery disease during the study.
9. Use of tobacco products (for example, cigarettes, cigars, pipes, and snuff) within
the 6 months prior to Visit 1.
10. Requirement for treatment with very potent inhibitors of cytochrome P450 3A4 or
inhibitors of cytochrome P450 2D6.
11. Requirement for treatment with inducers of cytochrome P450 3A4.
12. Active infection/inflammation as determined by body temperature >38°C OR current use
of systemic antibacterial, antifungal, or antiviral medication OR active chronic
inflammation (for example, lupus, rheumatoid arthritis, multiple sclerosis).
13. Abdominal, thoracic, vascular, or cranial surgery that is determined to be of major
significance by the investigator within 3 months prior to Visit 1.
14. Current suspicion of carcinoma or treatment for cancer within 6 months prior to Visit
1 or anticipated treatment for cancer during the course of the study, with the
exception of superficial lesions such as basal cell carcinoma and squamous cell
carcinoma of the skin.
15. Patients who have taken any non-steroidal anti-inflammatory agents (including aspirin
and cyclooxygenase-2 inhibitors) or vitamins within 14 days of entry (Visit 1).
16. Patients who have previously completed or withdrawn from this study or any other
study investigating LY333531 (unless the patient is being re-screened 14 days or more
after discontinuing the use of vitamins or non-steroidal anti-inflammatory agents.
17. Directly affiliated with the conduct of this study, or are immediate family of
someone directly affiliated with the conduct of this study (that is, Lilly employees,
investigators, site personnel, or their immediate families). Immediate family is
defined as a spouse, parent, child, or sibling, whether biological or legally
18. Treatment with an investigational drug within the last 30 days at the time of study
19. Females of child-bearing potential (not surgically sterilized and between menarche
and <5 years post menopause) who test positive for pregnancy at the time of
enrollment based on a serum pregnancy test or who intend to become pregnant during
20. Females of child-bearing potential who do not agree to use a reliable method of birth
control (for example, use of oral contraceptives or Norplant®; a reliable barrier
method of birth control [diaphragms with contraceptive jelly; cervical caps with
contraceptive jelly; condoms with contraceptive foam; intrauterine devices]; partner
with vasectomy; or abstinence) during the study.
21. A female who is breast-feeding.
22. Any other findings, in the opinion of the investigator, that would preclude the
patient's participation in the study.