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Todd Hobbs Part 1, The Pioneer One Study

In part 1 of this Exclusive Interview, Todd Hobbs talks with Diabetes in Control Publisher Steve Freed about the results of their Pioneer One Study, the first to report on oral semaglutide, and what it means for people with type 1 and type 2.

Todd Hobbs is vice president and US Chief Medical Officer for Novo Nordisk.


Transcript of this video segment:

Steve Freed: We’re here at the American Diabetes Association’s 78th Scientific meeting, and we have a very special guest with us who’s going to give us all the scoop and all the new things that are happening from the studies from Novo Nordisk. So I’d like to say maybe you can just give us a little bit of what you do, what your responsibilities are.

Todd Hobbs: I’m with Novo Nordisk and I’m currently the chief medical officer in the U.S., and I really serve as the medical voice on a lot of issues. But many times they’re data related, as we are here at this ADA session, and this year as I think you’re aware we’ve got a lot of data across many areas. Thirty-nine total abstracts and although no big CBOT reveal this year we do have a lot of exciting, I think from our perspective, and hopefully interesting data from an attendee and clinician and even patient perspective. So a lot going on.

Steve Freed: So let’s just jump right into this with the Pioneer One study. Can you tell us about the results of the Pioneer One and different approaches used in the analysis.

Todd Hobbs: Sure, so let me handle the first part of that and then we’ll dive into the analysis after that. The Pioneer One is the first of our Pioneer 3A program to report out for oral semaglutide. And there’s 10 different trials and they’re numbered in fact in order based on essentially where a type 2 diabetes patient would be in their journey with type 2 diabetes. So Pioneer One for instance is very early in therapy, those who are really going on OADs for the first time. And we’re looking at all three of the doses of oral semaglutide versus placebo. So there’s four different arms, the three doses that we’ve chosen that we’re investigating and are in our Pioneer program are 3, 7 and 14 MG; certainly once we apply for our indication with the FDA we’ll see how they view these doses but those are our intended maintenance doses and the data was very strong as you could imagine against placebo; those three doses were statistically significant and better in regards to A1C lowering, and also in regards to weight reduction  Semaglutide,  we know from Ozempic, which is currently approved in a weekly injectable has a very strong effect on glycemia but also positive effect on an individual’s weight. And so we’ve seen that as well in the oral. formulation.

Steve Freed: What does it mean for people with type 1? We know it works well [in type 2]

Todd Hobbs: Well at this at this point either injectable semaglutide, which is approved, or oral semaglutide, we’re not studying in type 1 at this time; certainly down the line that may be something we would consider but right now it’s focused on type 2 patients only. So we did study Victoza in the past in type 1 patients, and we know clinicians currently may try to use that off label; we’re not pursuing an indication either for Victoza or at the current time for semaglutide in type 1 patients.

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