In part 4 of this Exclusive Interview, Dr. Aaron Vinik talks with Diabetes in Control Publisher Steve Freed during the AACE 2017 convention in Austin, Texas about the untapped possibilities of Cycloset.
Aaron Vinik, MD, PhD, FCP, MACP is the Director of Research and Professor of Medicine, Pathology and Neurobiology at Eastern Virginia Medical School in Norfolk, Virginia. His research and recent discovery of a gene, INGAP, could prove to be a cure for diabetes.
Transcript of this video segment:
Steve Freed: Three years ago, I asked you what’s the most exciting things coming out of ADA and you said it was cycloset. I said cycloset? It’s a postprandial drug, it reduces blood sugars insignificantly. There’s better drugs out there to reduce postprandial blood sugar. You said forget about postprandial blood sugars you reduce your risk for base by 55% percent. And now we know that SGLT2’s it might be 35%, but nobody here is talking about cycloset and it showed to be much more effective. Now, is it because it was a smaller study? But even if it was why aren’t we seeing research or money being put into that to get the results out in a larger study because if it’s really 55% I mean it should be put in our drinking water.
Dr. Vinik: Now you put your finger on what the problem is. The problem is that was a safety study, it wasn’t powered to do that and nor was it the primary endpoint. So you have the nay-sayers out there that say show us the money and what they mean by that is that the study is going to be conducted in such a way that this fulfills your primary endpoint. That’s one of the reasons why you cannot use the information about the reduction of macrovascular events with EMPA or LIRA because in essence you wanted to have that as your primary endpoint and look what your primary endpoint would turn out to be, heart failure. It’s not reduction of coronary artery disease, it’s not reduction of coronary events, it’s a reduction of heart failure and at the same time as a reduction of mortality. So why doesn’t the company go out there and do a big study? The problem with that is they are not a big company, they are a small company. A small company hoping to eek by and getting people’s attention and fulfilling the promise that this drug has. Do I think that I personally am guilty of over predicting for this? I haven’t changed my tune with regard to what the possibilities are. It has those possibilities and I think those same things are lurking around the corner as to how SGLT2 inhibitors work and how LIRA may have worked better. That’s the best way I can explain that. You know because when you starting thinking about so many other trials that we’ve done and we’re looking for what the primary end points are and if we haven’t fulfilled them then we haven’t won the game. But there are other drugs out there.
I’ll give you an example if you want, if you look at the Metanx trial, Vivian Fonseca’s trial published in the American Journal of Medicine, they set out to show that they could improve neuropathy and they used vibration perception threshold as the endpoint and the problem with that was very simple. Nobody has ever shown that you can improve vibration perception, ever. So why use that as an endpoint? You know you’re going to be slammed in the face when it happens. But fortunately enough, they used another tool. The NTSS-6 as a pain tool with 6 varieties of pain and the SF-36, which is a quality of life tool. Guess what happened? Pain went away and quality of life improved. So they managed to sell their nice, sweet little company to a much bigger company and that bigger company is called Nestle and now it gets to be a food. And everybody is going to be interested in that food because it improves your quality of life. So maybe if we had been smarter in the studies that were created around cycloset and had quality of life and improved people’s quality of life, this could have been a quality of life tool. But I will show you, if anybody’s around at my session tomorrow on heart failure, that you can predict the glycemic response to cycloset by the changes in heart rate. So if you change a person’s heart rate, then get a beneficial effect of lowering of the heart rate you will get an appropriate and equivalent lowering of the A1c. Have you heard that before?
To view other segments in this video series:
Part 1: INGAP Research
Part 2: Heart Failure and Diabetes
Part 3: Reversing Heart Disease