Effects of TUDCA on Endothelial Function in Type 2 DM

This is a pilot study designed to investigate the effect of two doses of TUDCA on endothelial
function.All subjects will receive 500 mg/day in a one week run-in period and then 1750
mg/day in one week treatment period. The study will consist of four visits (screening visit
and three study visits), and last up to 2 weeks for individual subjects, depending on the
time between visits. It is estimated that the study will last two years from IRB approval
through data analysis.

Inclusion Criteria:

- Type 2 diabetes mellitus defined as fasting glucose greater than or equal to 120
mg/dL, HgA1C ≥6.5% or ongoing treatment with hypoglycemic medication.

- Willing to give written informed consent and able to understand, to participate in and
to comply with the study requirements.

Exclusion Criteria:

- Women lactating or pregnant. All women with childbearing potential will undergo a
urine pregnancy test at each visit to exclude pregnancy.

- Treatment with an investigational product within the last 30 days.

- Clinically evident major illness of other organ systems, including end-stage cancer,
renal failure, or other conditions that in the opinion of the principal investigator
make a clinical study inappropriate.

- Inability to provide informed consent.

- Clinical instability that would preclude withholding medications as determined by the
study physician.