Waking Beta Cells Study
Study Name: Targeting Beta Cell Dysfunction in Longstanding T1D
Principal Investigator: Carla Greenbaum, MD
WHAT IS THE WAKING BETA CELLS STUDY?
We are recruiting Seattle-area adults for this JDRF-funded study to test whether two drugs, liraglutide and golimumab, can temporarily “wake-up” beta-cells in type 1 diabetes patients with longstanding diabetes.
Type 1 diabetes (T1D) is an autoimmune disease in which the immune system mistakenly attacks the cells that produce insulin (beta cells in the pancreas). As beta cells are destroyed by immune cells, the body’s ability to produce insulin is decreased and diabetes develops. After diagnosis, the remaining beta cells continue to be attacked by the immune system. The beta cells stop working well and then most eventually die off.
To make insulin, beta cells first make pro-insulin. This is then split into insulin and other products. Only insulin itself has effects on blood sugar. Beta cells that are not working well can’t make fully formed active insulin but they can make pro-insulin. We have recently found that many people who have longstanding type 1 diabetes have beta cells that make pro-insulin, but not insulin. We call these “sleeping beta cells”.
The objective of the Waking Beta Cells Study is to determine whether either of the study drugs, liraglutide or golimumab, can wake up the sleeping beta cells, at least for a short while.
Both study drugs are FDA-approved for other conditions. Liraglutide (Victoza) is commonly used in type 2 diabetes. Golimumab (SIMPONI) is approved for use in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
WHO CAN PARTICIPATE?
You may be eligible to participate if you:
- were diagnosed with type 1 diabetes at least three years ago
- are age 18 through 50
- live in the greater Seattle area
- are in good general health
WHAT WILL STUDY PARTICIPANTS BE ASKED TO DO?
First, a researcher will have a phone conversation with you to review initial screening criteria. If you meet initial criteria, you’ll be invited to Benaroya Research Institute’s clinical research center at Virginia Mason Hospital for a four-hour screening visit that will include an MMTT (mixed meal tolerance test). This visit will be repeated within a three-month period.
If you are found to be eligible to participate, you will visit us three or four times during a two-month period, and administer the study drug at home between visits.
Eligible individuals may choose to participate in the liraglutide study, golimumab study, or both (given a 90-day washout period between the first and second study drugs).
If you’d like to participate, please call us at 800-888-4187 or email firstname.lastname@example.org.