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Study Finds Low-Dose Anti-Thymocyte Globulin (ATG) Preserves Insulin Production in People Newly Diagnosed With Type 1 Diabetes

Nyhet: TrialNet - 25 juni 2018

Findings from a new TrialNet research study show low-dose thymoglobulin (ATG) slows insulin loss in people newly diagnosed with type 1 diabetes. The findings were presented today at the 2018 American Diabetes Association’s Scientific Sessions in Orlando, Florida.

Study Chair and TrialNet Investigator at University of Florida Michael Haller, M.D., said, “We are excited to share these important findings with all those affected by type 1 diabetes and are eager to conduct studies designed to test ATG even earlier in the disease process, prior to symptoms and clinical diagnosis.”

ATG is approved by the FDA to prevent or treat acute rejection of a transplanted organ. A previous pilot study tested ATG in combination with pegylated granulocyte colony stimulating factor (GCSF), an FDA-approved drug used to increase white blood cell counts in people receiving chemotherapy. The pilot study suggested that ATG combined with GCSF preserved insulin production for more than one year after treatment in people who had type 1 diabetes for four months to two years.

TrialNet researchers wanted to know if ATG alone or in combination with GCSF could slow insulin loss when started earlier. To find out, TrialNet enrolled 89 people between age 12 and 45 diagnosed with type 1 diabetes in the past 100 days. Some people received ATG, some received ATG combined with GCSF and others received a placebo.

One year after the start of treatment, researchers concluded:

    Low-dose ATG preserved beta cell function and improved insulin production.

    Low-dose ATG combined with GCSF did not enhance beta cell preservation.

    Hemoglobin A1c levels were significantly lower (indicating better long-term blood sugar control) in people treated with low-dose ATG alone and in people treated with low-dose ATG combined with GCSF, as compared to placebo.

All participants will complete the study by August 2018. Final findings will be reported in 2019.

TrialNet Chair Carla Greenbaum, M.D., Director of the Diabetes Research Program and Clinical Research Center at Benaroya Research Institute in Seattle, said, “Based on these promising findings, TrialNet is considering other studies to determine whether low-dose ATG alone or in combination with other agents may be more effective even earlier in disease progression. Though more research is needed, we’re hopeful this could be a much-needed avenue to prevent disease progression for people with new type 1 diabetes.”


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Barndiabetesfondens ordförande, senior professor Johnny Ludvigsson kommenterar:

Än så länge bara ett abstract vid American Diabetes Associations pågående kongress, och kort uppföljning av patienterna, men det ser ändå ut som att låg dos av ett medel som blockerar effekten av T-celler bidrar till att bevara kvarvarande insulinsekretion vid typ 1 diabetes. Dels stöder dessa fynd existerande föreställning att åtminstone när sjukdomsprocessen väl är igång så spelar den autoimmuna processen roll för att insulinproduktionen minskar, dels kan det visa på en väg att hitta kombinationsbehandlingar där man kan öka effekten utan att samtidigt öka biverkningarna.

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