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Researchers to report first results from highly anticipated type 1 diabetes intervention trial


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Chantal Mathieu, MD, PhD
Chantal Mathieu, MD, PhD

Researchers will present the first findings from a key trial during the symposium Type 1 Diabetes Intervention Trials, which will take place at 4:00 p.m. CT on Saturday, June 4, in La Nouvelle Orleans Ballroom C at the convention center. The symposium will also be available livestreamed for virtual meeting attendees.

The trial analyzed the use of low-dose interleukin-2 (IL-2) in recently diagnosed type 1 diabetes.

“This is going to be a very exciting session with results from this highly important trial,” said session chair Chantal Mathieu, MD, PhD, Professor of Medicine, Katholieke Universiteit, Leuven, Belgium. “This trial and others are trying to interfere with the immune system to stop—or at least slow—the destruction of beta cells. Investigators are trying to target the immune system to help it behave more appropriately—to not attack, but rather to regulate and tolerate the insulin-producing beta cell.”

The goal of the trial is not immune suppression, but improved immune regulation, Dr. Mathieu said. Nor is it the only type 1 diabetes intervention trial that uses familiar immune system regulators to improve beta-cell survival.

Francine R. Kaufman, MD
Francine R. Kaufman, MD

Type 1 Diabetes TrialNet founding member Jay S. Skyler, MD, MACP, Professor of Medicine, Pediatrics and Psychology at the University of Miami Leonard M. Miller School of Medicine, will open the two-hour symposium. The TrialNet consortium has been at the forefront of type 1 diabetes research and screening trials since 2001.

“Dr. Skyler will start with an overview of past efforts in prevention and arrest of loss of functional beta-cell mass, and thus arrest of type 1 diabetes,” Dr. Mathieu said. “We will discuss the hurdles and challenges, then open perspective with the efforts of TrialNet and INNODIA, a European trials consortium, on finding novel biomarkers for type 1 diabetes and how innovative trial design can help us progress.”

Researchers are using low-dose IL-2 with the goal of slowing progression in recently diagnosed type 1 diabetes by reducing destruction of beta cells. Low-dose IL-2 preferentially promotes the generation of regulatory T cells rather than cytotoxic T cells both in vivo and in animal models.

“Every clinician knows that having some beta-cell mass left makes all the difference in people living with type 1 diabetes,” Dr. Mathieu said. “Having some functional beta-cell mass left gives you a lower risk of hypoglycemia and more stable glucose control. Potentially, you have less hyperglycemia and a lesser risk of complications.”

Results from the IL-2 trial will be presented by David R. Klatzmann, MD, PhD, Professor of Immunology, Chief of Biotherapy, and Coordinator of the Clinical Investigation Center in Biotherapy at Pierre and Marie Curie Medical School and Hôpital Pitié–Salpêtrière, Paris.

“I’m looking forward to hearing these results,” said Francine R. Kaufman, MD, Chief Medical Officer at Senseonics Inc., and Distinguished Professor Emerita of Pediatrics at the University of Southern California. Dr. Kaufmann will provide independent commentary on the trial results.

“Prevention trials in type 1 diabetes were first started under National Institutes of Health funding in 1992-93,” she said. “Thirty years later, we still don’t have a therapy to preserve beta cells in the clinical arena. These are the kind of trials that can affect what we do today, next year, and in the next couple of years. This trial could be the next chapter in type 1 diabetes prevention and cure, which is top-of-mind for everyone at the Scientific Sessions.”