Teplizumab Delays Clinical Diagnosis of Type 1 Diabetes an Average of Two Years, According to Study Presented at ADA's Scientific Sessions

SAN FRANCISCO, June 9, 2019 /PRNewswire/ -- The Teplizumab Prevention Trial has given validity to the concept that immune therapy can delay the diagnosis of type 1 diabetes (T1D), according to findings presented at a symposium entitled "New Therapeutic Approaches and Insights for Type 1 Diabetes" today at the American Diabetes Association's^® (ADA's) 79th Scientific Sessions^® at the Moscone Convention Center in San Francisco.

Family members of someone with T1D have a 15 times greater risk of developing T1D than individuals from the general population. Testing can determine the presence of autoantibodies, indicating risk for T1D, and the development of abnormalities in glucose tolerance identifies individuals nearly all of whom will develop clinical T1D. This study enrolled relatives of patients with T1D based upon these findings suggestive of high-risk. The participants were randomly assigned to treatment with teplizumab (an FcR non-binding humanized monoclonal anti-CD3 antibody) or placebo. Overall, the teplizumab treatment group within this study experienced an average two-year delay in the onset of T1D compared to the placebo group.

Teplizumab interferes with the body's auto-immune response, and previous clinical trials have shown teplizumab prolongs insulin secretion in people with a recent diagnosis of T1D. During this seven-year study in relatives at-risk, 72% in the placebo group were diagnosed with T1D as identified by an oral glucose tolerance test, compared to 43% of patients who received the teplizumab. Further, the teplizumab-treated group saw a reduced annualized rate of diabetes of 14.9% compared to 35.9% within the placebo group.

"This is the first time we have showed that immune therapy can delay progression to type 1 diabetes," said study investigator Kevan Herold, MD, Professor of Immunobiology and Internal Medicine at Yale University. "Type 1 diabetes is one of the most common chronic diseases of childhood and is also diagnosed among adults. Our results offer great hope to family members and possibly in the future to the general public who may be at risk for developing type 1 diabetes."

Researchers conducted the double-masked, placebo-controlled, randomized trial of 76 participants, 55 of whom were younger than age 18. Using the database from TrialNet's Pathway to Prevention study, researchers identified relatives of people with T1D, and those with multiple antibodies and abnormal glucose tolerance were eligible for assignment to the Teplizumab Prevention Trial. Participants received either teplizumab or a placebo over 14-days with daily, 30-minute intravenous drug infusions at TrialNet Clinical Centers. Researchers followed participants until 42 of the enrolled participants were diagnosed with T1D. Two study participants were lost to follow up. Researchers observed, as with other trials involving teplizumab, short-term side effects of a rash and low white blood cell count that resolved. Results were found to be highly statistically significant and with great clinical relevance.

"We hope to bring wider recognition to the fact that type 1 diabetes is an auto-immune disease that can be treated with immune therapy, similar to other autoimmune diseases," said Carla Greenbaum, MD, Director of Diabetes Clinical Research Program at Benaroya Research Institute in Seattle, and Chair of Diabetes TrialNet. "We now understand that essentially all close relatives of people with type 1 diabetes and who also have multiple antibodies can be considered as having the early, asymptomatic form of the disease. Just as we treat the asymptomatic presence of hypertension to prevent a heart attack or a stroke, these findings provide strong evidence we are approaching a future in which we can identify and treat type 1 diabetes long before symptoms occur."

TrialNet is comprised of physicians, scientists and healthcare teams funded by the National Institutes of Health Diabetes, Digestive, and Kidney Diseases (NIDDK), with additional support from the ADA and JDRF. TrialNet's mission is to identify individuals at risk for clinical T1D and to conduct clinical trials to stop the disease's progression. TrialNet has tested more than 200,000 relatives and has collected data and samples for more than a decade with the dual aims of creating an improved understanding of T1D and of creating new trials, such as those employing combination therapies or those targeting individuals who are more likely to respond to therapy.

To speak with Dr. Herold or Dr. Greenbaum, please contact the ADA Press Office on-site at San Francisco's Moscone Convention Center on June 7-11, by phone at 415-978-3606 or by email at SciSessionsPress@diabetes.org.

The American Diabetes Association's 79th Scientific Sessions, the world's largest scientific meeting focused on diabetes research, prevention and care, is being held June 7-11, 2019, at the Moscone Center in San Francisco, California. Nearly 15,000 leading physicians, scientists, health care professionals and industry representatives from around the world are convened at the Scientific Sessions to unveil cutting-edge research, treatment recommendations and advances toward a cure for diabetes. During the five-day meeting, attendees receive exclusive access to more than 850 presentations and 2,000 original research presentations, participate in provocative and engaging exchanges with leading diabetes experts, and can earn Continuing Medical Education (CME) or Continuing Education (CE) credits for educational sessions. The program is grouped into eight thematic areas: Acute and Chronic Complications; Behavioral Medicine, Clinical Nutrition, Education and Exercise; Clinical Diabetes/Therapeutics; Epidemiology/Genetics; Immunology/Transplantation; Insulin Action/Molecular Metabolism; Integrated Physiology/Obesity; and Islet Biology/Insulin Secretion. Gretchen Youssef, MS, RDN, CDE, President of Health Care and Education, delivered her address, "It's All About Access!," on Saturday, June 8, and Louis H. Philipson, MD, PhD, FACP, President of Medicine and Science, will deliver his lecture, "Precision Medicine—Addressing the Many Faces of Diabetes," on Sunday, June 9. Join the Scientific Sessions conversation on social media using #ADA2019.

About the American Diabetes Association
Every day more than 4,000 people are newly diagnosed with diabetes in America. Nearly 115 million Americans have diabetes or prediabetes and are striving to manage their lives while living with the disease. The American Diabetes Association (ADA) is the nation's leading voluntary health organization fighting to bend the curve on the diabetes epidemic and help people living with diabetes thrive. For nearly 80 years the ADA has been driving discovery and research to treat, manage and prevent diabetes, while working relentlessly for a cure. We help people with diabetes thrive by fighting for their rights and developing programs, advocacy and education designed to improve their quality of life. Diabetes has brought us together. What we do next will make us Connected for Life. To learn more or to get involved, visit us at diabetes.org or call 1-800-DIABETES (1-800-342-2383). Information is available in English and Spanish. Join the fight with us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn).

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SOURCE American Diabetes Association