At Virta Health, one of our greatest prides is that our treatment is based on health outcomes instead of platitudes about ‘better health.’ Central to this is our clinical trial focused on type 2 diabetes reversal. Based out of Lafayette, Indiana, this trial has been testing the effectiveness of Virta’s treatment since 2015.
Dr. Amy McKenzie, PhD, has been an integral member of Virta’s research team. She was one of Virta’s first hires, helped launch the clinical trial, and is an ambassador of our research to the broader science community. She was awarded the Young Investigator Award at the National Lipid Association Conference in April, and received similar recognition at the American Diabetes Association Scientific Sessions last week. We are proud of her accomplishments, and look forward to the contributions she will continue to make as a Senior Research Scientist at Virta.
A graduate of The University of Connecticut’s Exercise Physiology PhD, Dr. McKenzie will be responsible for future research strategy. I spoke with her about the beginnings of the Virta clinical trial, the most recent discoveries, and her aspirations for Virta in the coming months and years.
Sarah: Hi Amy. Thank you for the time -- I know you’ve been very busy with your presentation at the ADA last week! Before I ask you to share about the results you debuted, can you lay out the beginnings of Virta’s clinical trial for readers?
Amy: Sure! From August 2015 through March 2016, we enrolled 262 patients with type 2 diabetes and 116 patients with prediabetes and metabolic syndrome in a study that would evaluate the impact of the treatment provided by Virta on their metabolic health over the next 2 years. We also enrolled a group of patients with type 2 diabetes who selected to continue the care they were already receiving from their PCPs, endocrinologists, and diabetes education program as an observational comparison. And last year, we amended the trial protocol to extend it to 5 years for participants in the intervention group if they were willing to continue participating. While the components of our treatment are based on decades of research, this is the first prospective, longitudinal study to evaluate the combined effects of these components in the care model we created at Virta.
Sarah: Without repeating your entire presentation, could you tell us some of the key findings from the prediabetes cohort?
Amy: Here’s what I think is most important: The initial studies on the Diabetes Prevention Program (DPP) and the long-term follow ups have given us a lot of insight regarding the key drivers for preventing progression to type 2 diabetes or delaying its onset. In the DPP, participants with prediabetes who regressed to normoglycemia, even transiently when they collected data at 1, 2, or 3 years into the intervention, had a 56% reduced risk of developing type 2 diabetes. In general, we expect 5-10% of people with prediabetes each year to either progress to type 2 diabetes or regress to normal blood glucose. In our study, 82% of participants with prediabetes remained enrolled in the study, which is pretty good considering all of the extra things we ask participants in research studies to do. And, 61% of those who completed one year testing, regressed to normal blood glucose with an HbA1c less than 5.7%. No one-year completer progressed to type 2 diabetes.
Sarah: So far, we have highlighted our 1-year type 2 diabetes health outcomes and cardiovascular risk factor changes, but there are a couple of other presentations our team has done in the last few months. Can you briefly cover some of those findings?
Amy: At the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), my colleagues Drs. James McCarter and Nasir Bhanpuri presented the estimated pharmaceutical cost savings resulting from the reduced need for diabetes medication with our treatment. Annualized diabetes medication cost for our patients was $4,438 per patient, and at one year, this annualized cost was reduced 46% to $2,329 per patient, with the biggest contributor to that being insulin, which was reduced or eliminated in 94% of participants.
And then at Digestive Disease Week, Dr. Shaminie Athinarayanan and our collaborators, Eduardo Vilar-Gomez and Naga Chalasani, presented on the impact of our treatment on surrogate markers of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). NAFLD is present in about 70% of patients with obesity and type 2 diabetes and it’s associated with increased risk of heart disease and chronic kidney disease. In our study, NAFLD, measured by the NAFLD liver fat score, was present in 95% of our participants with type 2 diabetes. Virta patients had significant improvements in this score, and the prevalence of suspected steatosis was reduced form 95% to 70% at one year.
Sarah: Looking beyond the clinical trial, you also have been leading a Herculean charge with our Virta Patient Registry. For those that are unfamiliar, what exactly is the registry? How will the data be used? Why does it matter?
Amy: From a research perspective at Virta, our goal is to improve health outcomes for patients. Pure and simple. And the reality is that there’s a lot we don’t fully understand yet, so I think there’s a lot of value in gathering initial insights from this observational data and it’s also something we can and should contribute to the broader medical and scientific communities to drive more even research. Our mission with the Virta Health Registry for Remote Care of Chronic Conditions is to utilize data volunteered by patients receiving care at Virta Health for their chronic condition to do just that, to gather insights on the types of patients and conditions we treat, explore ways to improve care for chronic conditions with particular attention to personalization and understanding who benefits most from what, and ultimately, for those efforts to translate to even better health outcomes for patients. We want our learnings to have the opportunity to improve health for all patients living with type 2 diabetes, not just our own, so we plan to share our learnings both in self-published reports and in the peer-reviewed literature so everyone can learn and make informed decisions.
Sarah: What can people expect from our research team in the next year?
Amy: More data! When people discuss our approach to regaining glycemic control that combines nutritional ketosis with continuous care via telemedicine, the first comments I usually hear are things like, “looks promising, but we need more evidence on x, or y, or z”, or “sure, you can do that for a few months, but is it sustainable?”. We want to understand more about all of these things too! So the research team at Virta wants to help answer these questions by contributing evidence to the scientific and medical literature in a way that’s applicable to the real world and everyday life for people with insulin resistance. We are currently submitting a few papers on secondary one year outcomes for peer review like markers of NAFLD and sleep quality, and starting to analyze 2-year data for patients with type 2 diabetes and prediabetes, so watch for those!
Sarah: I personally feel so fortunate to have you on the team, and am excited to see what you will do going forward as a Senior Research Scientist at Virta. Could you share some ideas of where you foresee Virta’s research going?
Amy: In general, I think our research is going to help fill knowledge gaps in the medical and scientific literature and, I hope, serve as a foundation and springboard for other scientists to learn more about how this intervention works relative to their area of expertise and within their patient populations. At Virta, patient health outcomes are at the center of everything we do, so we’ll be working on everything from providing patients and clinicians with the evidence they need to make informed treatment decisions, to learning how we can better serve our patients and what other patient populations might benefit from our care, to understanding the treatment’s impact on cost to both patients and payers.
Sarah: I’ve asked a lot of questions about your work, but not a lot about you. Some may not know, but you were one of Virta’s earliest employees. What initially drew you to our team? And, if it’s different, why are you still with Virta?
Amy: There are two things that drew me to Virta at the time. One, is that I like being challenged and solving problems, and I felt like working at Virta was going to give me the opportunity to work on solving a really big and important problem. And the second reason, is why I think diabetes is a big and important problem in the first place. And that’s because diabetes isn’t an isolated disease. If you have diabetes, you’re not only concerned about diabetes, you’re also concerned about obesity, dyslipidemia, cardiovascular risk, your kidneys… And having diabetes and its comorbidities doesn’t only affect you, it also affects the people who care about you. So I want to contribute to a solution for diabetes that keeps people healthy so they can enjoy life with the people who care about them. And why am I still here? Simple, if there’s one thing I know for sure, it’s that I don’t know everything. And since I’ve joined Virta, I’ve learned a lot, but mostly I realized how much more we don’t know, so I’m still here because we still have a lot to understand on our way to helping 100 million people tackle their diabetes!
Sarah: Is there anything else you would want to add about your experience, or is there something else you wanted to touch on?
Amy: Definitely! I certainly didn’t get to where I am today on my own, I’ve had plenty of great mentors and teammates along the way and I owe them a lot of thanks for helping me find a career I was going to enjoy, taking time to help me understand what I couldn’t on my own, and being great role models for the type of scientist and person I want to be. I’ll spare you my mushiness, but I am incredibly grateful for my family, Drs. Jason Sciebek, Susan Yeargin, Derek Kingsley, and Larry Armstrong, and the whole team at Virta for inspiring me, teaching me, and being some of the best mentors, supporters, colleagues, and friends anyone could ask for.