Researchers at UW Medicine in Seattle seek adults recently diagnosed with type 1 diabetes for a clinical trial of an investigational drug that may protect insulin-producing cells from destruction.
Type 1 diabetes is a disease in which the body’s immune system attacks the cells in the pancreas that make insulin, gradually leading to a loss in a patient’s ability to make insulin. This study will involve an investigational treatment that might help preserve that capability.
The test drug, CNP-103, was developed by COUR Pharmaceuticals, an Illinois-based company.
“The drug targets T cells, immune cells, that are mistakenly attacking the pancreas. By neutralizing these T cells, the drug aims to protect the insulin-producing cells and potentially extend their function for years beyond what would normally happen,” said Dr. Irl Hirsch, a diabetes expert and professor of medicine at the University of Washington School of Medicine.
He is the lead investigator at UW Medicine’s South Lake Union trial site, one of 31 U.S. study locations.
Who can enroll at this study location?
Adults ages 18 to 35 with a type 1 diabetes diagnosis within six months Currently taking insulin only, no other diabetes medication Still producing some of their own insulin (to be confirmed via pre-enrollment screening) No other significant medical problems Participants must live in western Washington.
What does participation involve?
10 total visits over a 13-month study span: 28 days for screening, 90 days for treatment and 275 days of follow-up. At least three of those visits will include an infusion of the test drug or placebo delivered through an IV. (A later phase of the trial might involve more infusions.)A $100 stipend per visit will be provided ($1,000 for completing all 10 visits).
This is a placebo-controlled, double-blind study. Neither participants nor the researchers will know which participants are designated to receive CNP-103 or a saline infusion.
At this stage of study, the researchers are primarily evaluating the drug’s safety and tolerability. A secondary goal is to understand whether the drug helps the body to keep making its own insulin by slowing the immune system’s attack on pancreatic cells.
The main safety consideration for CNP-103 is low blood sugar, or hypoglycemia, Hirsch said, “especially if the drug is having its intended effect and a participant’s body begins to produce more insulin.”
All participants will use a continuous glucose monitor and provide the research team with weekly glucose measures so insulin dosages can be adjusted as needed.
Rising adult burden of type 1 diabetes
Worldwide, type 1 diabetes affects some 8.4 million people. In the United States, upward of 65,000 people are diagnosed each year with type 1 diabetes. A half-century ago, the condition was called “juvenile diabetes” because the diagnosis was so rare in adults. Today about half of diagnosed patients in the U.S. are adults, with an average age of 24.
People with type 1 diabetes must vigilantly monitor their glucose and dietary intake to ensure their insulin intake (via pump or injections) is sufficient. This 24/7 monitoring and the accompanying lifestyle restrictions can cause anxiety, exhaustion and depression.
Chronically high blood sugar can seriously injure kidneys, the nervous and cardiovascular systems, and vision. The condition, like any chronic disease, also affects the finances of patients and their families.
For details: The UW Medicine researchers hope to recruit six to eight participants over the next six months. If you or someone you know was recently diagnosed with type 1 diabetes and may be eligible, contact Dori Khakpour at the UW Medicine Diabetes Institute: dorik@uw.edu.
For news organizations: Download broadcast-ready video soundbites and related multimedia with Hirsch.
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