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Jeffrey Emmick Part 2, Lilly Studies Combining GLP1 and SGLT2 Inhibitors




In part 2 of this Exclusive Interview, Jeffrey Emmick talks with Diabetes in Control Medical Editor Joy Pape about the combination of GLP1s and SGLTs while Diabetes in Control Publisher Steve Freed makes a quick appearance to ask about the possible effects of their combined use.

Jeffrey Emmick, MD, PhD, is the vice president of product development at Eli Lilly and Company.

 

Transcript of this video segment:

Pape:  So, are you doing any studies of using the GLP-1s and the SGLT-2s?

Emmick:  So, we actually already reported results from a study done as a part of our Trulicity program called AWARD-10. And that study was GLP added onto a background of SGLT-2 Inhibitors. So, exactly the question you’re asking, we know that with the increasing use of SGLT-2 Inhibitors and the demonstrated cardiovascular benefit in the case of Jardiance that there will be increasing use of the oral agent but eventually many patients will progress on to needing an injectable. So, we thought it was an important question. In fact, we were the first company to actually report on in a full phase 3 study that showed in this case Trulicity added on top of any background SGLT-2 Inhibitor, so they could come in on their background therapy. They were optimized on that therapy for a period of time and then randomized to placebo or Trulicity. What we showed in that study as you would have expected was further increase in A1C reduction when you added the GLP, further reduction in weight and really no significant difference in hypo events, so demonstrated both the efficacy of adding GLP-1 to an SGLT-2 Inhibitor as well as the safety. So, those results have been reported and submitted to regulatory authorities for labeling as well.

Freed:  And I’ll just add one. Did you see any benefits, analgesic effects, of weight, A1C when you combine those two and the improvement in the risk for death and for cardiovascular disease?

Emmick:  So, to the first question about whether the effects where synergistic, no evidence of synergism, probably slightly more than additive in terms. If you look at the individual effects of, let’s say, in SGLT-2 and the individual effects we’ve seen with Trulicity. Additive to slightly less in additive, not synergistic but certainly additionally once the end weight reduction as you would have — as we expected. In terms of cardiovascular events, of course this was a typical phase 3 diabetes study. And so, that would have to actually be tested in a full-scale cardiovascular outcome study. And it is a question of interest, given that Jardiance has demonstrated a cardiovascular event reduction and has a label for that. Victoza has as well. We’ve got the ongoing REWIND trial that we will see later this year. So, I think the big outstanding question is would the two together provide additional cardiovascular benefit versus each agent alone. It’s a great question. No one currently has proposed such a trial. It would be a very large trial. I think the other thing that’s becoming increasingly obvious to us as we have more classes that show a cardiovascular benefit, the challenge of showing additional benefit on top of those agents in large scale trials is going to become increasingly difficult. And so, I think that’s something important from kind of an agency perspective as we look at how we design cardiovascular outcome trials in the future. We’re going to have to consider that, because it becomes unethical to exclude something that’s showing a benefit in the placebo or standard of care arm, but it is a great question and one that remains unanswered.

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