Drug delays type 1 diabetes in people at high risk

Type 1 diabetes develops when the immune system's T cells mistakenly destroy the body's own insulin-producing beta cells. Insulin is needed to convert glucose into energy

Type 1 diabetes develops when the immune system's T cells mistakenly destroy the body's own insulin-producing beta cells. Insulin is needed to convert glucose into energy

The treatment is an anti-CD3 monoclonal antibody (mAb), which is being developed for the interception and prevention of type I diabetes and has been the subject of multiple clinical studies involving more than 1,000 subjects with more than 800 patients.

Of those, they chose the participants who had two or more type 1 diabetes autoantibodies and abnormal blood sugar levels.

Researchers gave the drug teplizumab or a placebo to a small group of people who were almost certain to develop type 1 diabetes, based on genetics and certain symptoms. "Teplizumab is the first immune modulator to show a delay in the clinical onset of type 1 diabetes". The median time to clinical diagnosis of T1D for placebo participants was just over 24 months.

"The difference in outcomes was striking".

The hormone insulin is vital for the conversion process and when the body fails to produce any or enough insulin, diabetes can develop. And they'll need to get better at identifying high-risk individuals who lack close relatives with Type 1 diabetes, he said.

The finding, which was published Monday in the New England Journal of Medicine, is noteworthy, supporting an idea first advanced four decades ago that led researchers to reconsider how Type 1 diabetes progresses. The research team also cautioned that the study had limitations, including the small number of participants, their lack of ethnic diversity, and that all participants were relatives of people with type 1 diabetes, potentially limiting the ability to translate the study broadly. "As anyone with Type 1 diabetes will tell you, every day you can delay this disease is important".

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The preventive benefit of treatment was greatest in the first year following treatment, which study researchers said reflects the very high risk of disease progression among children who tested positive for autoantibodies. The risk of Type-1 diabetes among children and adolescents is growing faster than adults. A total of 75% of participants who received teplizumab experienced a form of AE relating to blood or bone marrow, such as transient lymphopenia.

"While the results are encouraging, more research needs to be done to address the trial's limitations, as well as to fully understand the mechanisms of action, long-term efficacy and safety of the treatment", said Dr. Spain. "The dedicated researchers, volunteers and families participating in this program make discoveries like this possible". For more information, visit http://www.trialnet.org.

"This result also provides hope to type 1 diabetes families and the general community".

According to the developer of the drug Provention Bio Inc, it is necessary to conduct additional, more extensive studies before registering teplizumab as a drug.

Of the 76 patients included in the trial, 55 (72%) were aged ≤ 18 years; 44 received teplizumab, and 32 were given placebo.

Jeffrey Bluestone PhD, A.W.is Mary Margaret Clausen distinguished professor of metabolism and endocrinology at the UC San Francisco (UCSF) Diabetes Center, president, CEO of the Parker Institute for Cancer Immunotherapy, and a director of Provention Bio. Additional support comes from the Juvenile Diabetes Research Foundation and the American Diabetes Association. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases.

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