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Contact: Debbie Weeks, research associate, College of Pharmacy, 509-358-7733; Joshua J. Neumiller, assistant professor, College of Pharmacy, 509-368-6756

WSU Spokane Clinical Research Team Selected for Two New Diabetes Trials

SPOKANE, Wash. - Patient recruitment is underway for two diabetes-related clinical trials to be conducted through the College of Pharmacy at Washington State University Spokane.

One is sponsored by Duke and Oxford universities, while the other was developed by the Population Health Research Institute in Hamilton, Ontario, Canada, and offered to WSU through the University of Washington. It will develop data on whether the medication Januvia® makes a difference in cardiovascular outcomes in diabetic patients. Funded by Merck Inc., the trial will involve study sites in 33 countries and follow 14,000 patients for at least three years.

The new Population Institute trial will test whether adding a thiazolidinedione medication to the drug regimen of a person with diabetes will reduce the risk of heart disease, as well as whether the addition of vitamin D will decrease the risk of death and/or the risk of developing cancer. Funded by GlaxoSmithKline, the full trial will involve sites in 29 countries and approximately 16,000 patients who will be followed for up to 10 years.

Anyone who may be interested in participating in a clinical trial can contact Shannon Yedinak at 509-358-7729 or Debbie Weeks at 509-358-7733.

The WSU College of Pharmacy's Clinical Trials Research Team successfully completed its first-ever clinical trial for the National Institutes of Health (NIH) this past summer. Known as the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, it involved managing more than 140 patients during the past eight years. A second clinical trial involving 36 patients has been managed by the WSU team for the past three years.

The trial team's demonstrated proficiency in recruiting and caring for patients, following trial procedures and documenting findings during the course of the first two trials led to them being offered the two more-recent trials.

"Our specialty is long-term cardiovascular outcome trials," said Debbie Weeks, an experienced nurse who has worked more than 10 of those years with Dr. Carol Wysham, a Spokane endocrinologist and an adjunct research professor who heads the WSU team.

Weeks and Wysham and two other medical professionals made up the team that managed the NIH diabetes trial. WSU Spokane was one of more than 70 clinical trial sites for the NIH study which was designed to shed light on whether maintaining specific levels of blood sugar, blood pressure and cholesterol would reduce cardiovascular events such as heart attacks or strokes in persons with type-2 diabetes.

The WSU team also participated in two sub-studies of the NIH trial - one that focused on the patients' memory and the other on eye disease in relation to blood sugar, blood pressure and cholesterol goals. The results of those studies have yet to be released.

The trial participants were required to follow certain regimens and report at regular intervals to the Health Sciences Building on the WSU Spokane Riverpoint Campus, where the team and their examination rooms are located.

Weeks said patients are drawn to participate in clinical trials because of the free medical care, medications and extra attention that being part of a trial affords. The College of Pharmacy site rates high in being able to keep patients coming back, she said.

In 2006, the WSU Spokane trial team was enlisted to conduct a second five-year national study intended to compare how two different FDA-approved treatments for lowering cholesterol levels may reduce the risk of heart attacks, stroke and other cardiovascular complications. Co-sponsored by Abbott Laboratories, the trial involves more than 100 study sites. The WSU trials will look at the medication Zocor® alone and also in conjunction with Niaspan®.

Recently, the WSU trial team added a new member, Joshua J. Neumiller, an assistant professor of pharmacy at WSU and an experienced researcher and licensed pharmacist for the past four years. A certified diabetes educator and certified geriatric pharmacist, Neumiller has been with the WSU College of Pharmacy since graduating from the program four years ago.

Weeks got her national certification in clinical research more than 10 years ago and renews the certificate every two years through continuing education. She and the College's finance officer have completed an intensive training program for managing clinical trial finances and work closely together on trial budgets to ensure they do not cost the university money.

More information is available on the team's web page at:
http://www.pharmacy.wsu.edu/pharmacotherapy/clinicalresearch.html

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