Preserving Beta-Cell Function with Tocilizumab in New Onset Type 1 Diabetes (the EXTEND Study)

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Updated on 23 November 2020
Marla Inducil 
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Preserving Beta-Cell Function with Tocilizumab in New Onset Type 1 Diabetes (the EXTEND Study)


The healthy insulin-producing beta cells that you have left when you are first diagnosed with type 1 diabetes are precious. The aim of the EXTEND Study is to test whether a therapy called tocilizumab (Actemra®) can stop the immune system from attacking these remaining beta cells and possibly extend the ability to naturally produce insulin. Currently there are no approved treatments that are able to do this.

Participants in the EXTEND study will be randomly assigned to one of two groups. One group will be given the study drug, tocilizumab, and the other group will receive an inactive substance made to look like the study drug, called a placebo.

Tocilizumab or placebo will be given once every 4 weeks over a 24 week period. There will be a total of 7 intravenous infusions with four additional follow-up visits during the next 18 months. Total study time is 2 years.

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Clinical Study IdentifierTX140078
Last Modified on23 November 2020


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Inclusion Criteria

You may be eligible to participate in the EXTEND Study if you
Are male or female, aged 18-45
Have been diagnosed with type 1 diabetes within the last 3 months
Are in good general health
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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