In part 1 of this Exclusive Interview, Dr. Samuel Engel talks with Diabetes in Control Publisher Steve Freed during the ADA meeting in San Diego, California about the results of the new SGLT-2 ertugliflozin.
Dr. Sam Engel is the Associate Vice President, Cardiometabolic and Women’s Health at Merck Research Laboratories.
Transcript of this video segment:
Steve Freed: This is Steve Freed. We’re here at the American Diabetes Association, 77th Scientific Studies and we’re here to present to you some exciting interviews from some of the top endos from all over the world and we have with us a special guest, Dr. Sam Engel. And maybe you can give us a little background on who you are, what you do and why you’re here.
Samuel Engel: Thanks, Steve. Well I’m here because this is obviously a very important meeting for diabetes investigators and researchers. I’m the section head for diabetes at Merck research labs in our late stage development group and we have obviously a wide variety of posters and presentations here related to a number of different efforts that we’re working on.
Steve Freed: Ok so, I notice here that you have a couple of important studies and one of the new SGLT-2’s, that’s an oral. That is kind of unique because everybody else’s is pretty much injectable. No, that’s a GLP-1. I’m sorry. So, the ertugliflozin is a new SGLT-2 that is before the FDA and you had a couple of presentations. What were the results and what were you presenting? The important issues.
Samuel Engel: We have a total of five different presentations here at ADA this year related to ertugliflozin. There are two studies that are being presented for the first time, 26-week data. One is the VERTIS SITA study and the other is the VERTIS MET study, VERTIS is the name of our clinical trial program. VERTIS SITA looked at the co-administration of ertugliflozin and sitagliptin in patients who were not well-controlled on a background of diet and exercise. It’s a complement to a study that we previously presented, VERTIS Factorial, which was also a co-administration but on a background of metformin. In the results of that study, what we saw were very consistent changes from baseline in A1c reduction, about 1.6-1.7% versus 0.4% with placebo, in very similar changes from baseline as what we saw on a background of metformin. The second new data set is VERTIS MET; this is a placebo-controlled study of ertugliflozin in patients on a background of metformin therapy, so second-line therapy. These data, 26 weeks, again showed very similar efficacy responses both in terms of glucose as well as weight and blood pressure as we’ve seen throughout the entire program, about a 0.7 and 0.9% reduction with the two doses of ertugliflozin. VERTIS MET is important for another reason, it’s actually a two-year study, and we’re presenting the six-month data. This is a study that is going to be looking at bone health. We are following bone mineral density in patients in this study and the study is also enriched with a higher proportion of women who are at risk for osteoporosis in this study. So we are presenting at this meeting the six-month data on bone mineral density and we are pleased to see that. you know, in terms of the bone mineral density, we don’t see any adverse impact at that time point with either the 5 or 15 mg doses of ertugliflozin.