Diabetes In Control. A free weekly diabetes newsletter for Medical Professionals. News and information for Medical Professionals.
In part 1 of this Exclusive Interview, Rachele Berria talks with Diabetes in Control Publisher Steve Freed about the various trials of interest presented at the conference, such as the latest regarding the study of two basal insulins.
Rachele Berria is global vice president and head of medical affairs at Sanofi in Bridgewater, New Jersey.
Transcript of this video segment:
Freed: This is Steve Freed and we’re here at the American Diabetes Association, 78th Scientific Sessions. And we have a special guest with us, Rachele Berria. Is that correct?
Berria: Correct. Yes.
Freed: And maybe you can tell us a little bit about your background. We know that you’re Vice President and Head of Diabetes Medical Unit at Sanofi, Bridgewater in New Jersey, which is kind of a unique position for a woman. We’re seeing women getting higher in the food chain and it’s interesting. And being involved with diabetes is very interesting, which is kind of unique. I only saw one other CEO today that was a woman, but that’s two more than last year. So, maybe we could start out with telling us a little bit about yourself and what you do.
Berria: Absolutely. I earned by MD degree in Italy. As part as my residency program, I moved to the US. And I’ve been passionate about diabetes for the past 25 years. And I believe this is my 21st ADA and Orlando has a special meaning to me because 14 years ago the ADA was in Orlando and my son was turning one month here. I was still working at the University of Texas and I had an oral presentation, and I wouldn’t miss that for my life, and so I came with my mother. And my mother was sitting in the back of the room with my not-even-one-month old, that it made me proud as a professional and as a woman. And since then I continued working in diabetes and joined Sanofi eight years ago. And it matches my realness of doing things differently and this is what we want to do in diabetes from funding early research and partnering with the ADA. In fact, for very, very fascinating new projects and fostering young scientists to working with technology with continuous glucose monitoring up until the real world evidence and its applications to compliment the randomized clinical trials.
Freed: Now, you’re having — I was just told 70 papers, abstracts, posters, presentations, 70 — and that’s all within four days. Obviously, you have a lot to say, so maybe you can kind of highlight the data that you’re the most excited about.
Berria: Absolutely. I’m really proud about our massive presence here at the Scientific Sessions. Clearly it’s a result of teamwork and a lot of passion. The highlights of this ADA are our Toujeo, our long-acting basal insulin analogue, the first head-to-head randomized clinical trial versus another long-acting basal insulin called degludec. And in this study, we show that both insulins at the end of the treatment reached comparable hemoglobin A1C lowering, about 1.6%, and overall equal incidence and event rate in terms of symptomatic and severe hypoglycemia. However, in the triation period Toujeo seemed to have lower incidents and even rate of both symptomatic and severe hypoglycemia. And some clinicians think that for patients that are starting an injectable, specially basal insulin, this period of adjustment is specially important for them. And having less hypoglycemic events may mean that they will stay on therapy and they will reach A1C target. So, that’s only one of the studies that we have but it’s complemented by a whole housed of real world evidence both from electronic medical records up until machine learning with a very comprehensive database that covers more than 5 million lives. It’s the Optum-Humedica database that we’re mining with artificial intelligence and natural language processing. So, this is for Toujeo. I’m also really, really proud about Zynquista, this is the proposed brand name for our SGLT2 and 1 inhibitor, sotagliflozin. I’m very passionate about type 1 diabetes as well. I come from an island, Sardinia, which has the second highest incidence in the world of type 1 diabetes, only after Finland. And I think that with so many options that we have for type 2 diabetic patients, for type 1 for the last 100 years we’ve had insulin and only insulin. So, there’s an opportunity that this could become an additional option for the patients and their clinicians to treat type 1 diabetes. And of course, every medication comes with benefits and risks that will be evaluated, but this has been sent to the FDA for their review and accepted, and we look forward to the dialogue with them. And there’s three studies. In fact, very important studies with Zynquista presented here at the ADA in Tandem 1, in Tandem 2, and an interesting analysis with continuous glucose monitoring. You will also see data on Praluent [which] is our PCSK9 inhibitor. And this data shows that Praluent in patients with either normal glycemia or pre-diabetes or diabetes still is highly effective in preventing cardiovascular events. I could continue on and on but this is really the highlight of the meeting for us.
Freed: How is Sanofi utilizing real world evidence to study the safety, efficacy, and the value of its diabetes products?
Berria: We believe it complements the randomized clinical trials. It’s not either/or. The clinical trials, the classic ones, are helpful for the review with the health authorities and answer the question of, “Can this product work for our patients?” And then, the second also equally important question is, “Will this product — will these results be generalizable to the whole population that the clinicians treat?” And we think that this question is better answered by the real world data and the different ways that we can analyze that in a way that we’ll be able to test the efficacy, the effectiveness, and the safety of our drugs, and potentially even subgroups of patients that can benefit the most out of these drugs.