Question-and-Answer Session
Operator
(Operator Instructions) Your first question comes from Mike Weinstein of JP Morgan.
Mike Weinstein - JP Morgan
Let’s start off by spending a minute on the additional clinical work that you’re going to be doing over the next several months and to make sure we all have that down.
Mark Knudson
We are currently enrolling in a trial that we are calling ENABLE and that trial will evaluate approximately 35 or 40 type 2 diabetic patients. We will look at what happens with those patients, A1C, as well as several glucose homeostasis hormones over at one month, six months, and twelve months. That trial is currently enrolling and we expect enrollment to be completed before the end of this year.
Mike Weinstein - JP Morgan
In your discussions with the FDA, assuming you see the outcomes that we’re seeing thus far in this early data, it’s only 35, 40 patients. What can you do with that and how can that be incorporated, if at all, into the ultimate label?
Mark Knudson
I think a lot of that will depend on what we see in the diabetic sub-study portion of the EMPOWER trial, but certainly it will give us the data we need to do a pivotal trial on these two indications as we move forward. Any other advantages or acceleration will actually have to wait until further conversation with the FDA.
Mike Weinstein - JP Morgan
And from, I know we’re talking about small numbers here, but from the diabetic patients that you evaluated here in this study, the ranging of the response between the patients, do you have any hypothesis on why some patients are having a greater response than others or any thoughts on that?
Mark Knudson
Well as you point out this is a small number, but we did have a fairly wide range. In fact I think the highest A1C that we saw in this trial was slightly over 12 and that patient had a dramatic response getting down to 8 which is actually pretty good in those conditions. So we do believe that there is a direct effect and it may be related to delayed gastric emptying as well as an affect on the hormones that control insulin and glucose production, which are very much vagully mediated effects. We don’t know at this point and we expect to try to understand that as part of the ENABLE trial.
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