12 Responses

  1. julie
    julie August 6, 2010 at 8:59 am | | Reply

    I often wondered for those adults who get type 1 later in life if there are more Type A personalities who get this diagnosis. Really busy productive folks who maybe put their health after all the other stuff they do until getting type 1 disease.

  2. Carol
    Carol August 6, 2010 at 9:54 am | | Reply

    I'm always glad to read about studies that address the autoimmune process gone haywire that causes the destruction of the beta cells, and even more excited when they have shown promise in human trials. And LOL on the T1 brilliant folks! More and more it seems like the brainpower I devoted to diabetes distracts me from remembering things like where I left my coffee cup. Or maybe that is just middle age:).

  3. Melitta
    Melitta August 6, 2010 at 11:26 am | | Reply

    I am curious why the Defend study excludes people over the age of 45 with new onset Type 1 diabetes. That seems to leave out a significant portion of the Type 1 population. Just as an example, former Assistant Surgeon General of the United States, Dr. Kenneth Moritsugu, who was diagnosed at age 49, would have been excluded from this study.

    Congratulations, Joy, on your new career/adventure!

  4. Scott K. Johnson
    Scott K. Johnson August 6, 2010 at 5:36 pm | | Reply

    I love this guest post! Thanks Amy and thanks Joy!

    Maybe I am biased, but I too think there's something special about so many that live with type 1 diabetes. :-)

  5. kim
    kim August 7, 2010 at 8:39 pm | | Reply

    I also wonder why those diagnosed with Type 1 after the age of 45 are excluded from studies. I was diagnosed 2 years ago at 49. I was very willing to participate in research, but no studies were available to newly diagnosed people my age.'

  6. The Lost Arts Of War
    The Lost Arts Of War August 8, 2010 at 5:39 pm |

    The Lost Arts Of War... interestin post over at . . ....

  7. Joy Pape
    Joy Pape August 9, 2010 at 6:37 am | | Reply

    Glad some of you found the post interesting. Here's why the cut off point for DEFEND-2 was 45 years old... Both Tolerx and the FDA were concerned about enrolling people who had Late-Onset Autoimmune Diabetes of Adulthood (LADA),or a mix of type 1 and type 2. People who are older when diagnosed with LADA have a greater likelihood of also having insulin resistance. The presence of insulin resistance would skew the outcome of the study agent, otelixizumab (OTE). If OTE is efficacious, there is much additional trial work to be done, e.g., in people with LADA, as prevention, etc. Stay tuned, and do keep the DEFEND-2 trial in mind for people you come in contact who are 12-45 years old, and newly diagnosed with type 1. If you need more information, please do contact me.

    Okay all you brilliant people who read, keep learning.


  8. Joy Pape
    Joy Pape August 9, 2010 at 6:39 am | | Reply

    Sorry for the typo...this is the correct link to LADA

    Thanks again,

  9. Kim
    Kim August 12, 2010 at 9:18 am | | Reply

    Thank you for the explanation of the exclusion of new Type 1s over the age of 45. I was 49 at diagnosis. I do not have LADA, nor do I have insulin resistance. I have Type 1. Is this really that unusual? I have discussed this many times with my endocrinologist, who also has Type1. He is convinced I do not have LADA. I do not fit the pattern of LADA. The media seems to perpetuate the "myth" that all adults diagnosed with autoimmune diabetes have LADA. Is straight Type 1 in adults no longer recognized?

  10. Joy Pape
    Joy Pape August 15, 2010 at 9:52 am | | Reply

    Kim, yes, it's still recognized. It's just that in the population over 45 there are many who do have LADA, and who do have insulin resistance. In clinical studies, it's important to keep a study "as clean as possible", so there are certain criteria to do so. For example, DEFEND2 also has criteria that adults' BMI must be <32. Weighing more could be related to insulin resistance.

    I hope this helps.

    Thanks again and EnJOY!

  11. Patton
    Patton December 9, 2010 at 9:48 am | | Reply

    This study sounds very interesting and promising for improving the life of Type 1 diabetics even though it is not a cure. I would like to make this option available to patients. How can I get patient materials? Also, when we see some results from this trial? Thanks

  12. Joy Pape
    Joy Pape March 11, 2011 at 1:57 pm | | Reply

    Hi all,

    We received some discouraging news today about the DEFEND 1 Study.

    Tolerx, Inc. and GlaxoSmithKline (GSK) today announced that the Phase 3 DEFEND-1 study of otelixizumab, an investigational humanized anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint of change in C-peptide at month 12 in patients with new-onset autoimmune type 1 diabetes.

    The good news is that there were no new or unexpected treatment-related safety concerns have emerged during the DEFEND-1 study.

    So what does this mean for DEFEND-2?
    GSK will continue to explore additional dosing regimens to inform decisions about the future clinical development programme for otelixizumab. New recruitment and dosing in the DEFEND-2 study, the ongoing confirmatory Phase 3 study with a design similar to DEFEND-1, has been suspended pending review of the DEFEND-1 results.

    Read more at:
    Tolerx and GlaxoSmithKline Announce Phase 3 Defend-1 Study of Otelixizumab in Type 1 Diabetes Did Not Meet Its Primary Endpoint
    I'll let you know more when I know.

    So, for now we continue to search for a cure and better treatments...

    Thank you for all your support.


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