seeing the HbA1c change they took, and I hope I am right about this, the value right
before they had to go on the rescue medication. So that’s just for the purposes of
determining how much of an HbA1c change there was.
analyses stop when you need to be rescued then you only count the value that
occurred right before rescue’. My first reaction to that was, Oh, that’s kind of icky
because those are not randomized sub groups. on the other hand, it’s consistent with
what we do in blood pressure trials, which is, if you are trying to look at the change in
blood pressure someone who hits a level that where they need to be treated with
something else we do take the last, I mean we have in the past taken the last, observation
right before they went on that additional medication. So it’s consistent with what we
have done when I was at NHLBI in those blood pressure trials. So I think it makes sense.
I am concerned about lumping them all together partially because it’s such small
numbers. You would think that the people who go on to the rescue probably are at an
increased risk of events. So on the one hand I was little bit curious about did the events
all occur in the people who went on to rescue or was it evenly split between the people
who stayed in their study and didn’t need rescue.
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be wrong on this but, what you were just saying is implying that if someone in the short-
term trial if they needed glycemic rescue they weren’t included in the long-term trial.
DR. BURMAN: Point of clarification is that correct?
DR. WOLF: Yes.
DR. BURMAN: Thank you. Are there any other comments?
DR. WYNE: I just had a brief comment about these events. I don’t think
DR. BURMAN: If I may, for a point of clarification and I definitely could
DR. PROSCHAN: No, no, no. What I am saying is, for the purpose of