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Study

Discussion in 'General Discussion' started by mom2Hanna, Aug 8, 2013.

  1. mom2Hanna

    mom2Hanna Approved members

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  2. mmgirls

    mmgirls Approved members

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    Is your daughter still being followed? I wonder if your DD is having any lasting benefits past the study duration. I am always hopefull for these prevetative and early onset sttudies, having a another child with very high chances of developing T1.
     
  3. mom2Hanna

    mom2Hanna Approved members

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    She's not being followed for that study, she was for 2yrs post study. But she did go into a second study because anecdotally they noticed when they interviewed people who had received this drug, none of them had ever had a severe low where they needed assistance. My daughter goes low and can even be loopy and want me to fetch juice or whatever because she wants me to, but she's never had a truely serious low. So Hanna did a study to see if her body rebounded and it did, it was an info gathering study to apply for funds to do a larger scale study. I haven't heard anything on that one. That Hanna got that drug, I am so grateful.
     
  4. nanhsot

    nanhsot Approved members

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    So did your daughter do the one year repeat drug then? My son was in a study with this drug as well, but he only got one round of it, the second round was supposed to be done a few months later and he chose to discontinue for a variety of reasons. The study was discontinued at that point anyway, so I'm not sure how they concluded it.

    Basically he got a single dose, did your daughter get 2, a year apart?
     
  5. Ellen

    Ellen Senior Member

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    Any side effects from the drug (immediate, or longer term)?
     
  6. Lenoremm

    Lenoremm Approved members

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    I believe they stopped the study in patients recently diagnosed with type 1 because it was failing to meet efficacy expectations as measured by A1c. I remember at the time (fall of 2010 I believe) thinking a measure of C peptides might be a better way to measure if the drug is actually preserving beta cell function.

    It is interesting to learn they are now measuring the C peptides in this study of the same drug.
     
  7. mom2Hanna

    mom2Hanna Approved members

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    Hanna got 2 rounds a year apart. Side effects, she developed her adhesive allergy during the study, but other then that nothing I have noticed. Other then the lack of severe lows which is a side effect I'm quite fond of, though I don't rely on it. She was 50 at 3am and sound asleep. :(
     
  8. joshualevy

    joshualevy Approved members

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    Just to fill in some details, there are a total of 9 clinical trials which have been done on this drug. One of them was stopped. That was a phase 3 trial that was the "twin" of another phase 3 trial (the FDA requires two for approval). The first phase 3 trial failed to meet it's primary end point, and so they stopped the second-identical study. The primary end point was a combination of A1c and insulin usage. C-peptides were measured, but were a secondary outcome, and this was true for all the phase 3 trials for this drug.

    I agree with Lenoremm that C-peptide is a much better primary end point than A1c. Combining A1c and insulin usage is better than A1c alone, but still not as good as C-peptide. Those studies started in 2006, which means they were designed prior to that. My guess (but only a guess) is that similar studies done today would use C-peptide as the primary end point. The FDA has issued guidance that treatments attempting to cure type-1 diabetes can use C-peptide as a substitute end point. And I think that these days, most are.

    Joshua Levy
     

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