In part 2 of this Exclusive Interview, Dr. Samuel Engel explains the effects of ertugliflozin on typical biometrics in a conversation with Diabetes in Control Publisher Steve Freed during the ADA meeting in San Diego, California.
Dr. Sam Engel is the Associate Vice President, Cardiometabolic and Women’s Health at Merck Research Laboratories.
Transcript of this video segment:
Steve Freed: So, in that study, if we kind of just went over some of the things that many physicians would look at is weight, blood pressure, A1c, and lipids. What were the results? What did you find?
Samuel Engel: Ok, so in the VERTIS MET study, A1c reductions were 0.7% and 0.9% for the 5 and 15 mg doses.
Steve Freed: And how did it perform on the secondary points?
Samuel Engel: Ok, so on the secondary end points, in regards to percent of patients at A1c goal as well as the secondary endpoint for weight and blood pressure, we saw very consistent responses with what we’ve seen across the entire program.
Steve Freed: You know every drug in the world has side effects. You couldn’t name a drug except, I wouldn’t call it a drug, but even water has side effects, too much or too little. What about the safety profile and the side effects did you find out in this study?
Samuel Engel: So both in the study as well as across the entire program, of course you know safety is something we need to look at very carefully and tolerability. You know to this point looking at both this study and the entire program, we see a safety and tolerability profile very similar to what’s been seen with other members of the class. There are higher rates of genital mycotic infections of both women and men generally, but other than that the safety profile really hasn’t identified any specific signals or concerns.
Steve Freed: What additional value would you want to provide to physicians as they leave. Do you want them to take some information with them? What would you like to provide?
Samuel Engel: Well, you know when I look at the ertugliflozin clinical development program, you know what we’ve done is really tried to focus on the spectrum of diabetes treatment choices and the studies that we’ve done, many of which are being presented here at ADA, really look at the use of ertugliflozin across the treatment paradigm both as initial therapy, monotherapy, or initial therapy in combination with sitagliptin, second-line therapy on top of metformin, or third-line therapy on top of patients who are on metformin and sitagliptin. That spectrum is very important to understand because clearly patient choices in regards to anti-hyperglycemic medications really need to be individualized or a different context. What I can tell you is that across the spectrum we’ve seen very consistent responses in regards to A1c, blood pressure and weight.