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Question about the T-Rex Study

Discussion in 'Research' started by rhill, Jun 22, 2017.

  1. rhill

    rhill New Member

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    I was reading Joshua Levy's blog on current T1D research. He mentions that the Phase 1 results of the T-Rex study showed that "the basic results were that after two years, these patients continued to generate C-peptide at the same rate as when they started the trial. There was no drop off in C-peptide production. That means there was no drop off in insulin production."

    To me this sounds like they have successfully halted the autoimmune attack for at least two years. If that is the case then this is a significant breakthrough. Is my understanding of the results correct?

    Here is the link to his article in case anyone is interested: http://cureresearch4type1diabetes.blogspot.com/search?q=T-Rex
     
  2. joshualevy

    joshualevy Approved members

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    I'm glad you found my blog post useful.

    I think it is reasonable to say that they have halted (or delayed) the autoimmune attack for two years, so I think your understanding of the results is correct. The big question is: is this a "significant breakthrough". Everyone has different definitions of what constitutes a significant breakthrough.

    I'm a little nervous about labeling this as a significant breakthrough, for a couple of reasons:
    • In the previous few years, there have been a couple of treatments which have had similar results. For example: Abatacept (Orencia), Etanercept (ENBREL), and Teplizumab. I think all of these were measured after one year, rather than two, but still: they kept C-peptide production constant for that time. But, so far, none of these have led to a cure or a treatment.
    • The "clinical results" were not very strong. Clinical results are things a normal person would notice. The treated patients (on average) still injected insulin, still had type-1, and generally didn't notice any improvement. Now, by comparing them to "average" people with type-1 diabetes, the researchers can tell they did better, but I think "clinical results" would be much more significant than these sorts of "research results".
    • The researchers are going to combine this treatment with IL-2 in a future clinical trial, and I think that is interesting. However, the clinical trial that would get me excited much more would be a "presymptomatic" clinical trial. Type-1 experts, by examining TrialNet data, have found that essentially everyone who tests positive for two or more autoantibodies, will eventually be diagnosed with type-1 diabetes. So I would like to see these people treated with a T-Rex like treatment. Since they do not have the symptoms of type-1 diabetes at this early stage, if their C-peptide production remained constant, then it is possible that they may never come down with type-1 diabetes (or that it would be delayed for years). That would be significant, in my mind! It suggests that these same results, if seen in different patients (those earlier in their T1D journey), would have a big impact.

    Joshua Levy
     
  3. samson

    samson Approved members

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    Hi Josh,
    Is no one attempting to do a kind of daisy-chain of treatments in people: For instance -- maybe each of these delays declines in insulin production for a year or two - perhaps stringing them together could produce 5 years of better blood sugar control?
    Perhaps this doesn't solve the day-to-day grind of diabetes but it might reduce long-term complications significantly, if metabolic memory really plays a role in complications decades down the line.
    And have these people who have been in clinical trials with these drugs been followed long enough to see if their rates of complications are lower than for the general population?
     
  4. joshualevy

    joshualevy Approved members

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    I don't know of any clinical trial which is rotating through treatments like that.
    There are a few trials (very few) that are combining a treatment designed to stop the autoimmune attack and a treatment designed to promote beta cell regrowth. Also, there are a few trials which try to combine two multiple treatments with the same goal, usually stopping the autoimmune attack. But I have not heard of a rotation scheme.

    Trials which attempt to combine treatments have a lot more overhead and a lot more paperwork than clinical trails with only one treatment. Also single treatment trials are easier to interpret, generally need less people, etc.

    No. Clinical trials for type-1 diabetes are usually 3 months, 1 year, or 2 years long. Occasionally longer or shorter, but very rare to last 5-10 years required to measure long term complications.

    Joshua Levy
     
  5. rhill

    rhill New Member

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    Joshua, thank you for your reply. I would consider it a significant breakthrough if the honeymoon period can be extended by years, or better yet permanently. Simply because glucose control is much better at the start of the honeymoon period for most people. It definitely was for my daughter.

    A couple of thoughts:
    1) If they repeat the T-Rex treatment every x years I wonder if they can extend the honeymoon period indefinitely. Alternatively, it is possible that even a single treatment will have long term or permanent benefits.

    2) My understanding is that islet cells continuously regenerate but are destroyed by the ongoing autoimmune attack. If the autoimmune attack is halted then won't the islets regenerate and survive? If so, the T-Rex participants should see a drop in their insulin requirements over time.

    I hope they do a long term study of the T-Rex study participants to see what effects it has.

    Also, thank you for your blog. Reading about the ongoing research gives me hope that some day there will be a cure.
     

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