Clinical Trials Team

The Clinical Trials Research Team within the Department of Pharmacotherapy is based at WSU Spokane and led by Dr. Carol Wysham and Pharmacist Joshua Neumiller. They conduct clinical trials centered on the management of diabetes and its complications. The goals of the clinical research team are to conduct high-quality clinical research as a means to provide hands-on diabetes care to members of the greater Spokane community, and to improve the management and outcomes achieved for people with diabetes. If you have questions about any of our current studies, or think you might be interested in participating in clinical research, please contact Debbie Weeks.

Active Clinical Studies

EXSCEL

Currently enrolling participants

The EXSCEL Trial, EXenatide Study of Cardiovascular Event Lowering Trial, is a long term clinical trial examining the effects of once-weekly exenatide on lowering cardiovascular events compared to a placebo (inactive agent). People with type 2 diabetes that are on oral diabetes medications may qualify. There are other inclusion and exclusion that apply. As a participant you will be followed closely and optimal diabetes control will be encouraged. Optional nutrition and activity education will be offered.

This once weekly formulation of exenatide was recently approved by the FDA under the brand name “Bydureon.”

TECOS

Currently enrolling participants

The TECOS Trial, Trial Evaluating Cardiovascular Outcomes with Sitagliptin, is a long term clinical trial examining the effects of sitagliptin (Januvia) on cardiovascular outcomes compared to a placebo (inactive agent). People with type 2 diabetes that are on oral diabetes medications and/or insulin may qualify. There are other inclusion and exclusion that apply. As a participant you will be followed closely and optimal diabetes control will be encouraged. Optional nutrition and activity education will be offered.

Sitagliptin (Januvia) is FDA approved.

LEADER

Participant recruitment is closed.

The LEADER Trial, Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results is a long term clinical trial examining the effects of liraglutide (Victoza) on cardiovascular outcomes compared to a placebo (inactive agent). People with type 2 diabetes that are on oral medications and long acting insulin may qualify. There are other inclusions and exclusions that apply. As a participant you will be followed closely and optimal diabetes control will be encouraged.

Liraglutide (Victoza) is FDA approved.

CANVAS

Participant recruitment is closed.

The CANVAS Trial, CANagliflozin cardioVAScular Assessment Study, is a long term clinical trial examining the effects of canagliflozin on cardiovascular outcomes compared to placebo (inactive agent). Canagliflozin is an investigational agent that works on the kidneys to lower blood glucose levels, weight and blood pressure.

AIM-HIGH

Study concluded, currently in Follow-Up status.

AIM-HIGH was a five-year cholesterol management program funded by the U.S. National Heart, Lung, and Blood Institute (a part of the U.S. National Institutes of Health) with support from Abbott Laboratories.

WSU Spokane was one of 72 sites in the US participating in the clinical trial.
AIM-HIGH is currently preparing for a follow-up phase.

The study's national web site is: www.aimhigh-heart.com.

Action to Control Cardiovascular Risk in Diabetes (ACCORD)

Study concluded, currently in Follow-Up status.

The WSU Clinical Trials Research Team participated in this national trial for eight years, managing 142 patients until July 2009 when the trial concluded. The team is continuing to participate in the 5-year follow up study of its ACCORD patients. The trial was funded by the National Heart, Lung and Blood Institute in collaboration with the National Institute of Diabetes and Digestive and Kidney Diseases, the National Eye Institute and the U.S. Centers for Disease Control and Prevention. It was designed to determine the best ways to decrease the high rate of heart attack and stroke in people with type 2 diabetes. WSU Spokane was one of 72 clinical trial sites in the U.S. and Canada 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 Team also participated in two sub-studies of the trial – one that focused on the patients’ memory and the other on eye disease in relation to blood sugar, blood pressure and cholesterol goals. More information on ACCORD can be found at: www.accordtrial.org.

In 2010, the study was named one of the top 10 research reports for the year by the American Heart Association/American Stroke Association, which reported the first ACCORD study found that aggressive blood pressure control does not reduce CVD risk in people with type 2 diabetes at high risk for CVD. A second study found a combination therapy with a statin plus a fibrate was no better at reducing risk than a statin alone in patients with type 2 diabetes at high risk for CVD. However, the combination lipid therapy may be successful in reducing CVD risk in those type 2 diabetes patients who had low HDL cholesterol and low triglycerides.

The ACCORD Study Group published results in the New England Journal of Medicine, March 14, 2010: www.nejm.org.

 

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Debbie Weeks, Research Associate
1-855-228-0832
1-509-358-7733