In part 3 of this Exclusive Interview, Dr. Jim McDermott explains the DURATION-8 study of Bydureon and dapagliflozin combo therapy in a conversation with Diabetes in Control Publisher Steve Freed during the ADA 2017 Scientific Sessions in San Diego, CA.
Jim McDermott, PhD, is the Vice President of U.S. Medical Affairs, Diabetes at AstraZeneca.
Transcript of this video segment:
Freed: So maybe you can share with us some of the results from the DURATION-8 study?
McDermott: Yes happy to do so, in fact I have the numbers right here.
Freed: What were the drugs that we were looking at?
McDermott: So Duration8 was a combination of Bydureon and dapagliflozin. It’s initial combination therapy compared to the mono component, so it’d be compared to dapa[gliflozin] alone or Bydureon alone. So what we saw there was really some nice A1C reduction with the combination as well as weight loss and blood pressure reduction.
Freed: Can you share some of those numbers with us?
McDermott: Yes I would be happy to do so. I have the data right here.
Freed: Yes, that would be great.
McDermott: If you look at the A1C reduction we’re seeing a 1.75 with the combination vs. a 1.4 for the exenatide alone versus the 1.2 for Farxiga alone. So, you can see it’s not completely additive but it is a significant difference compared to the mono components.
Freed: Let me ask you a question: If someone has an A1C of 11 or an A1C of 7, the drop in A1C is not going to be the same. It’s not going to be the same; you can’t just say one number. So in looking at those numbers what was the average starting A1C?
McDermott: So in the Duration8 the average A1C at baseline was 9.3 across the three groups.
Freed: What were the other baselines?
McDermott: In terms of body weight, we’re looking at body weight in terms of kilograms. Pretty much it was 90-91kg across the three groups. Systolic blood pressure was across the three groups, again, the systolic was about 130.
Freed: GFR in those?
McDermott: As you know, Farxiga has a limitation in terms of its use with regards to EGRD. So in these patients, the baseline data, they had roughly a 95 EGRF.
Freed: So that is a huge drop in A1C.
McDermott: It really is actually.
Freed: You can actually put a dollar value on that. I guess that is how they price it. I think if you drop an A1C one point, you’re going to save thousands of dollars on a yearly basis; over a lifetime, it is very significant. I guess that’s one of the reasons why some of the drugs are so expensive. So what else is there in that particular study? It’s very interesting because I mean you have two drugs that are very powerful and they work very effectively together.
McDermott: So if I can share with you a little bit about what we saw too in some of the other efficacy parameters. So with weight, we saw a 3.3 reduction (kilograms) in the combined group versus a 1.5 reduction for an Exenatide, and then a 2.3 reduction for dapa[gliflozin]. So again, it’s not an additive but you do see a nice effect. Can I tell you a little bit about blood pressure?
Freed: Yes, please.
McDermott: So again, with the systolic blood pressure, we saw a 4.5 reduction in systolic blood pressure compared to a 3 millimeter reduction for exenatide, versus a 2.4 reduction for Farxiga.
Freed: And what about the side effects?
McDermott: Side effects as you would expect, we did not see any hypoglycemia, actually, which is very nice because both with the SGLT-2 and the GLP-1, you really see no hypoglycemia. That is really one of the true benefits or attributes of these two compounds. So, you’re getting great A1C reduction, but there is no risk of hypoglycemia.
Freed: For the patients that were put into the study, how many were there? And were they on other drugs or insulin?
McDermott: So within the study we briefly had 230 patients per arm and they were on metformin as background medication.
Freed: Newly diagnosed? It wasn’t prediabetes, it was newly diagnosed? Obviously for a person on metformin, I would not consider them long-term diabetics.
McDermott: They were not newly diagnosed. They were on metformin. If they were on other medications they would have been washed out but they would be on a stable dose of metformin. And you’re looking at patient with a very high A1C of 9.