In part 4 of this Exclusive Interview, Scott Abbott talks with Diabetes in Control Publisher Steve Freed during the ADA meeting in San Diego, California, about how studies have proven the effectiveness of the V-Go device.
Scott Abbott is the Director of Medical Development at Valeritas.
Transcript of this video segment:
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.