To see this the video of this interview, click here.
Steve: This is Steve Freed with Diabetes in Control and we are here at the American Diabetes Association 77th Scientific Session 2017 and we are here to present to you some really exciting interviews with some of the top endos from all across the world. We are going start off with a very special guest, Scott Abbott, who comes from a company called Valeritas. First, tell us a little bit about your background and what you do.
Abbott: Sure. What I do for Valeritas, I am the director of medical development and that involves a number of things for the company. Both in terms of product development with our V-Go insulin delivery device, but also new products and other technologies that we are working on. It also allows me to be involved within our clinical studies program and helping to design, analyze and publish and report on our clinical study findings as well.
Steve: Can you speak to the real-world implication in this year’s ADA data regarding daily control for diabetes patients?
Scott Abbott: Sure. We actually have two studies that have been presented or discussed here at the ADA meeting in 3 different abstracts. 2 poster presentations and 1 oral presentation that occurred this morning. What this means for patients is that it shows how the V-Go insulin delivery device can be used in the real world. These are real world or naturalistic study designs that are used in patients being treated by their clinicians in normal settings and it shows how the V-Go device can help improve patients’ A1c and typically by using less insulin to improve those A1c’s. We have done cost-effectiveness analyses to show the cost-effective benefit in using the V-Go insulin device in those patients.
Steve: So, tell us about the device.
Scott Abbott: Sure. This is the V-Go. It is a wearable insulin delivery device. Think of like a wearable insulin pen. It’s approved as a pump like device. And how it works, the rapid-acting insulin is used in this device. The patient would remove the cap, take the adhesive liner off and expose the adhesive. And they would put it on their body wherever insulin would normally be administered. They push down on the button and it releases a very small needle subcutaneously and has started delivering basal insulin. This device delivers both basal rate over 24 hours of insulin and also provides on-demand mealtime blousing when the patient needs insulin by pressing the buttons. Imagine, we are sitting at dinner or we are at a business meeting or I am at work or something to that effect, and I need to take my insulin. I don’t need to go somewhere to do it, I don’t need to grab things, I don’t need to carry things with me. I do this and administer the boluses I need to at mealtime or at snacks.
Steve: How do you adjust the dosage?
Scott Abbott: The V-Go has preset basal rates that are prescribed. Those basal rates last over 24 hours. The V-Go can have 20 units over 24 hours, 30 units over 24 hours, 40 units over 24 hours. And every V-Go has the ability for 36 units of on-demand bolus dosing for when the patient needs it throughout the day. To remove the V-Go you push down and pull back on the lever, there’s only 4 buttons, the needle is bound back into the device and you cannot re-deploy the needle again so you take the V-Go off and dispose of it.
Steve: You mentioned the bolus doses. So, if I want to have 40 grams of carbs one day, 6 the next day, how do I adjust for all that?
Scott Abbott: That’s up to the healthcare provider and you as to how to best control your diabetes and adjust the insulin to what you need.
Steve: How do I regulate the amount of insulin on a bolus? Because you have different units for different basals that can’t be adjusted, right?
Scott Abbott: You have preset basal rates.
Steve: That’s pretty standard as far as…it’s not going to go crazy overnight. But what about bolus? How do I adjust the dosage?
Scott Abbott: If your provider wants you to take a certain number ofunits, say he wants you to take 4 units, at breakfast then you would click this button twice, each click is 2 units. So if you need to take more at lunch, or depending on the carbs you eat or your prescribed regimen is, you would do that.
Steve: How often do people change those?
Scott Abbott: Once a day
Steve: So, every day you put on a new patch.
Scott Abbott: Every day.
Steve: And they come in packages of how many?
Scott Abbott: Typically, at the pharmacy you would get a box of 30.
Steve: It’s kind of similar to an insulin pump, so do you call this a disposable pump?
Scott Abbott: We call it a wearable insulin delivery device.
Steve: And the name of it is…
Scott Abbott: V-Go.
Steve: If you had to pick 5 things that these studies have shown that can improve someone’s life what would that be?
Scott Abbott: We have shown A1c reduction in patients who had A1c’s above 9 at baseline, approaching 10 in some cases. We have seen significant A1c reductions within a period of months. You do see the effective clinical improvement by changing the way that insulin is administered for patients to use
Steve: You’re comparing that to what?
Scott Abbott: One study was a prospective pragmatic clinical study done in patients, and the comparison was standard of care or standard treatment optimization. So, what we compared ourselves to was controlling the other medicines as clinicians normally would if they didn’t have access to V-Go and the arm that V-Go was in had the clinicians and patients had access to V-Go and they used in those patients, and that was the comparison, so we compared ourselves to an active control of controlling and optimizing other diabetes therapies.
Steve: How many different therapies were you comparing it to? There’s vials, there’s pens, there’s pumps….
Scott Abbott: There’s all different kinds of diabetes drugs, yes.
Steve: So, when you say this was effective in lowering A1C, is that a comparison…
Steve Abbott: Yes. It was an active comparison. So, patients were enrolled in their clinician’s offices and they had A1cs between 8-14%. They had to be on insulin, they were already on insulin injections. And they were either placed on V-Go as the insulin delivery device and the other insulin regimens were removed, but could’ve kept their other oral diabetes medications on board. Then the other arm they optimized whatever other diabetes medications the clinician wanted; they could have added other medications, taken medications away, added more insulin etc. Basically V-Go was being introduced into a patient population that was compared to standard treatment optimization so whatever the guidelines or the clinicians would do normally to treat diabetes, that’s what they would do. And what we saw was a significant reduction in A1c in both groups but more of an A1C decrease in the V-Go group. Importantly, as we have seen in nearly every other study with V-Go we saw a significant reduction in the amount of insulin being used in patients using V-Go. This is highly significant.
Steve: What would account for that? Because insulin is insulin and the requirements haven’t changed.
Scott Abbott: It’s interesting. In the control group, insulin dose largely did not change and in the V-Go amount it dropped by a good amount. It dropped by over 20%. That’s very typical in nearly all of our studies. What’s driving that is a little speculative, we don’t know exactly, but we can guess at a few things. One thing, being that this is a device that administers a continuous subcutaneous insulin delivery, we know that these types of devices have been shown in other clinical studies to typically reduce insulin need, compared to injections, by 20-25%, that has been demonstrated in other published literature.
Steve: So, we would see a reduction in insulin for insulin pumps then?
Scott Abbott: Yes, that has been shown in clinical studies compared to injections as well. The other thing too is if insulin is prescribed and patients don’t take all the injections every day for whatever reason. Injections can be hard to take for many reasons, and now they’re getting their insulin injections, that can also account for, “Hey all that insulin that was prescribed before maybe all that wasn’t needed and now you’re getting the insulin at lunch or whenever it’s needed because literally I’m clicking these buttons here on this delivery device that’s on me.” They are getting their insulin now when they need it with their meals and that could also, perhaps, result in this.
Steve: What are some of the other benefits?
Scott Abbott: We also did an economic analysis. We found that V-Go in the 2 analyses here as well as previous publications of analyses that we have done before, that there is cost-effectiveness and cost-benefits for using V-Go as compared to previous therapies they were on or to the control group that we were looking at in this prospective study.
Steve: Is that pre-filled or do you have to fill it?
Scott Abbott: You have to fill, and it’s filled with a U-100 fast-acting insulin.
Steve: Doesn’t make any difference what brand?
Scott Abbott: And the V-Go cleared for U-100 fast-acting insulin and we have done chemistry studies and can recommend the use of Humalog and Novolog.
Steve: Not Apidra?
Scott Abbott: We can’t recommend that, it’s currently not in our instructions for use. We do have the information available in our FDA labeling for the other 2 insulins.
Steve: Are there any other benefits that you have seen?
Scott Abbott: There have been some additional analyses that haven’t been disclosed yet. We are looking to publish those. It’s just the intrinsic nature of the device being on you and the patient having the ability to administer their insulin with this device on them. Which allows for the removal of some of the barriers that can be present in dosing insulin, in public for example, but also having the convenience and simplicity of having this on you at times as well tends to be a big improvement.
Steve: When was this FDA approved and when did it come to market?
Scott Abbott: It became available in 2012, so we have been steadily bringing this out across the United States since that time.
Steve: So, it’s been available for 5 years.
Scott Abbott: That’s right, we have publicly disclosed over 10 million days of therapy, so 10 million devices.
Steve: Is this approved for both type 1 and type 2?
Scott Abbott: It’s approved for adults who require insulin. So yes, type 1 and type 2 would apply. It’s mostly used in patients with type 2 diabetes. That’s who it was originally designed for mostly because of the insulin dosing I described earlier.
Steve: Are there any other factors that you have shown to be positive? There’s the convenience and a lot of other things.
Scott Abbott: There’s the insulin does…the economics are there. We do our analyses and most of our studies are done as real-world or pragmatic designs so that it can be applicable to the general population. And that’s important, because you want to know that a therapy can be used by a lot of different types of patients and patients that clinicians treat. What we do normally in our economic analyses is we use the acquisition cost of therapy price and we take a look at the cost of therapy for their diabetes management and patients who are on V-Go and not on V-Go. You see what the cost-factors are in terms of how much does it cost to treat diabetes to get a certain result, and we have seen the cost benefit for that.
Steve: What’s next for V-Go and I would assume it has something to do with the smart phones.
Scott Abbott: I can answer that in a lot of ways. What’s next for V-Go is to continue working on development of the device to simplify and make diabetes easier to manage for patients. That is our goal, to simplify and help patients manage diabetes better to continue clinical work and doing important things with our device. We have publicly disclosed a couple development projects, one involves something called V-Go link, which is a device that would attach to the V-Go and connect via bluetooth to a smart phone that would enable patients and providers, we hope, to better manage themselves and deliver insulin more effectively. So there is that technological development we’re working on. The other aspect is we are developing a pre-filled V-Go so instead of the filling that we described earlier there would be a pre-filled V-Go as well. Those are the two or three major technology things we are working on.
Steve: Have you decided which insulin the pre-fill is for?
Scott Abbott: No. No, we don’t have any information on that.
Steve: So, is there anything you want to let family practitioners and other medical professionals… first of all, you do you have a website I presume?
Scott Abbott: Yes, we have go-vgo.com and Valeritas.com so we have a couple sites there.
Steve: Are there videos on there?
Scott Abbott: There are several videos on the websites available, patient testimonials, how to use the product, there are a number of videos and resources that can be accessed on these websites to help everyone out.
Steve: What has been the response from the older population?
Scott Abbott: It’s been quite good. The fact that you can remove the burden of multiple injections and you can have this device on you and use it. I believe the numbers are over 40% of our patients are 65 years and older. It is actually under the Medicare part D as a drug benefit. So that is a huge help there. Most patients, I think over 90% of the patients, go to their pharmacy to get V-Go so they can get their V-Go with their insulins. So that’s a nice thing we have there.
Steve: Can they fill these early?
Scott Abbott: Yes, they would have to adhere to whatever the insulin is being used, the number of days you use prefill according to the insulin label. We can’t surpass the insulin label that’s approved, but it’d be on par with what is approved with those insulins.
Steve: Have you sold this any nursing homes?
Scott Abbott: It has been used in nursing homes. In fact I was the author of a publication that came out earlier this year. We did a small study in cooperation with a nursing home and found data that was quite beneficial in those patients. We found it contributed to better time in range, which is a term that describes when your glucose is in the 100-200 mg/dL range. We found that there was more time spent there. There was also a pretty significant reduction in nursing home time and therefore cost when using V-Go versus standard injections in the nursing home.
Steve: Is this available overseas?
Scott Abbott: It is not, it is only available currently in the United States. We have our marks in Europe so there is the possibility to go beyond the United States, but right now it’s only available in the United States.