Blog | 9/13/2024

Reflections on Recent Developments in Diabetes & Metabolics: Catching up with Industry Experts Dr. Shipra Patel and Sheela Hegde

By Monica Schroll, PhD, Aashni Parikh, and Rita Sa Ferreira, PhD

Photo: Sheela Hegde (left), Managing Partner at Health Advances, and Dr. Shipra Patel (right), Senior Medical Director, Endocrinology and Metabolism at Parexel, at the 84th ADA Conference in Orlando, FL.

We recently had the opportunity to sit down with two of our leaders in the field of diabetes and metabolic disease: Dr. Shipra Patel, Senior Medical Director, Endocrinology and Metabolism at Parexel and Sheela Hegde, Managing Partner and Diabetes Practice Leader at Health Advances, to get their perspectives on the latest developments in the field.

The discussion focused in particular on three fast-moving and high-impact technologies – the glucagon-like peptide 1 agonist (GLP-1) class, continuous glucose monitors (CGMs), and insulin pumps.

Key Takeaways

GLP-1 Drugs

The market boom for GLP-1 drugs is driving increased competition and investment in novel forms and combinations of related peptide agonists. Companies are focusing on differentiating their assets through more nuanced endpoints around diabetes efficacy, weight loss durability, lean:fat loss ratios, comorbidity impact, and tolerability. Additionally, there is opportunity for novel MOAs to be dosed in combination or in cycle with GLP-1s.
Optimistic view that expanded evidence for GLP-1 drugs will create a virtuous cycle: improve drug coverage and update clinical guidelines, which in turn will further increase adoption and improve outcomes.

CGM and Insulin Pumps

The CGM market is another exciting area of innovation, poised for further growth with the introduction of product options for type 2 and pre-diabetes patients, helping improve how diabetes is managed across all patient populations.
Innovations in insulin pumps are aimed at improving usability and automation, which should expand the use of these technologies in underserved patients, especially those with type 2 diabetes.

Overall, technological advances across therapeutics and devices are making strides in the clinical outcomes of diabetes patients. As we look to the future, the landscape of metabolic health is becoming increasingly interconnected as diverse modalities and mechanisms target interrelated metabolic conditions to provide more personalized and effective care. The challenges of access and adoption remain, but the trajectory is positive and leading to paradigm shifts in how these conditions are managed.

Below is a transcript of our discussion:

Tell us a bit about yourself and how you got into the field of Metabolics and Diabetes.

Dr. Shipra Patel: I am the therapeutic area section head for endocrinology and metabolism at Parexel, where I’ve been working for over 10 years. My team includes endocrinologists across the US, Latin America, Europe, and Asia. By trade, I am a pediatric endocrinologist and have worked in various endocrine areas, including obesity, type 2 diabetes (T2D), and type 1 diabetes (T1D). Recently, I have been more and more engaged around the large and evolving obesity field with GLP-1 receptor agonists and related compounds.

Sheela Hegde: I’ve been working in diabetes ever since I joined Health Advances in 2005. What initially drew me to the field was my work with a former Health Advances partner who has T1D – together we did high-impact engagements with emerging companies, non-profits, and market leaders. What has kept me interested in this space is the complexity of diabetes and the related challenges that we need to solve in the field – diabetes has both metabolic and autoimmune components, it spans across the biopharma, medical device, diagnostics, and digital industry sectors, requiring cross-sector innovation.

What excited you at ADA 2024 as it relates to the GLP-1 class?

Dr. Shipra Patel: There was a lot happening in diabetes with the GLP-1 class at this ADA. I was particularly excited about Novo Nordisk’s SELECT trial which showed that semaglutide resulted in a 20% reduction in CV events in adults with preexisting CV disease, overweight or obesity, without diabetes¹. Another exciting outcome was Lilly’s SURMOUNT trial showing tirzepatide reduced apnea-hypopnea index (AHI) in persons with moderate-to-severe obstructive sleep apnea². There was also a session about gastrointestinal side effects related to GLP-1 receptor agonists from a patient’s perspective, which I found particularly relevant. In general, as this is a very exciting area of research just keeping your pulse on the market is so important – but also extremely difficult given that the market is constantly evolving!

And how about at the EASD 2024, what excited you as it relates to the GLP-1 class?

Dr. Shipra Patel: I was particularly excited about Novo Nordisk’s presentations on the FLOW trial and their Phase 1 results for amycretin. The FLOW trial was terminated early due to its efficacy, with a 24% reduction in the risk of kidney disease-related events in patients with T2D and chronic kidney disease. This is a remarkable result as this trial involved a severe patient population. The phase 1 study with amycretin also produced exciting results, achieving 13.1% weight loss over 12 weeks of treatment³.

How do you anticipate the current boom in GLP-1 drug usage to impact the pharmaceutical industry as a whole?

Sheela Hegde: The rapid growth and popularity of this class is leading to dramatic investment in the next generation of products – whether that’s a novel MOA or a combination of incretins and non-incretins. As competition increases, companies are striving for ways to differentiate their new generation of products, either through weight loss durability, body composition/lean mass preservation, comorbidity impact especially in CVD and MASH, tolerability, and/or other endpoints.

What are your thoughts on the next wave of developing assets that are complementary to the blockbuster GLP-1s?

Dr. Shipra Patel: The topic of body composition/lean mass preservation is a big one right now and many products are being proposed either in isolation or in combination with the GLP-1 drug class. These include monoclonal antibodies that inhibit myostatin, novel GLP-1 receptor agonists guarding against muscle loss, or drugs that increase energy expenditure or mimic the effects of exercise⁴. One of the main goals of clinical trials will be to show the effects of GLP-1 and related drugs on aspects of body composition, which includes lean body mass and muscle volume changes, amongst other parameters.

Sheela Hegde: I would add that developers of next generation assets should also invest in data around comorbidities – diabetes, MASLD/MASH, CVD/HF, CKD – as relevant to their technologies and platforms. Early differentiating data on comorbid parameters also drives excitement in the field and in the markets.

There have been a lot of barriers to patients gaining access to GLP-1s, whether that’s through supply chain issues or lack of coverage. How do you see this evolving over time?

Dr. Shipra Patel: I am optimistic and hope that the expanded indications will improve drug coverage. When FDA or EMEA approved indications are on the label, you’re showing a higher value proposition which can help with updating clinical guidelines and updating coverage.

Sheela Hegde: Also, with market leaders investing in building out capacity and more companies entering the field, the supply issues should ease and better track to meet demand growth.

Now switching over to device innovation, what were your key takeaways from ADA and EASD 2024 on continuous glucose monitors (CGMs)?

Sheela Hegde: There were a lot of exciting updates on CGMs this year! We are seeing continued innovation to improve the form factor and ease-of-use of sensors. We’re also seeing stronger evidence on the outcomes that one can achieve with CGM technology – this will help shift CGMs from a niche technology used only by insulin-dependent patients, to a mainstream product that is used by non-insulin patients and beyond. It really signals that anyone with diabetes could benefit from sensor use, and I think that’s very exciting.

Dr. Shipra Patel: I completely agree, and you can really see how dramatically this is evolving. T2D patients historically never used CGMs and use in this patient population specifically is increasing rapidly. From the EASD conference, two interesting studies showed that T2D patients using CGMs, regardless of insulin use, had improvements in HbA1c outcomes and reductions in all-cause hospitalizations.

The recent FDA clearance of OTC CGM sensors marks a significant milestone in the evolution of glucose monitoring technology. How is this going to impact the commercial outlook for CGM?

Sheela Hegde: I think this underlines the value of the technology for really anyone with diabetes. If you look at the numbers for diabetes prevalence, around 30-40MM^5,6 in the US and 400-500MM⁷ globally, the commercial prospects are huge. As long as the evidence supporting the value of using CGM keeps expanding, access to the technology will increase, and the commercial benefits will follow.

What are your thoughts on the insulin pump market and developments that came out of ADA and EASD 2024?

Sheela Hegde: It’s been promising to see new pump platforms and algorithms that are striving to make insulin pumps more automated and easier for patients to use. Currently, there are 10 times as many T1D patients on pumps than T2D patients.⁸ Why is there this gap? Because pump technology is viewed to be expensive and hard to use by clinicians and payers. As pumps get easier to use and payers see evidence outcomes and value, we are likely to see expanded use in the T2D population as well, which is ~90%⁶ of the diabetes population.

Dr. Shipra Patel: The real headwind is that with more automation, patients need to self-manage their diabetes less, they need to do less and think less about their blood glucose management. You never know, with the way technology is improving here, it could become comparable to an islet transplant!

We haven’t really touched on insulin itself, but there are innovations here, with the once-weekly insulin results announced at EASD 2024. Any thoughts on this?

Dr. Shipra Patel: Once-weekly insulins could improve quality of life for people with diabetes, starting with those with T2D. Eli Lilly presented one of the week’s most highlighted sessions, sharing positive results from QWINT^14,15– in the phase 3 trial, Efsitora showed non inferiority to daily insulin in HbA1c reduction for both insulin-naïve adults with T2D and adults with T1D. For T1D, more studies are needed to optimize the dosing and minimize the incidence of hypoglycemia events. But for T2D, the burden of insulin dosing could soon be much better!

Finally, what are your thoughts on the next frontier AI-empowered apps to drive patient engagement and disease management?

Sheela Hegde: Diabetes has always been at the forefront of digital health innovation and will continue to be at the forefront of AI’s applications in disease management. ADA 2024 showcased AI's potential in optimizing insulin titration and predicting hypoglycemic events using CGM data.⁹ In addition, there are tools that can overlay EHRs to screen and identify patients at high risk of diabetes complications.¹⁰ There is no question that AI holds enormous potential to improve diabetes outcomes at the health system level.

Dr. Shipra Patel: Yes, it has been amazing to see the growth in AI applications for chronic disease management – in fact, I recall that there was a session at ADA about the pros and cons of using an AI dietary and lifestyle counselor! I think both Sheela and I were thrilled to hear about the latest digital health and AI innovations as well as the latest developments in the GLP-1 class across several therapeutic indications. We hope that these advances will translate into vast benefits for patients with chronic diseases.

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Monica Schroll, PhD, is an Engagement Manager and a member of the Metabolic and Autoimmune Practice at Health Advances.
Aashni Parikh is a Senior Analyst and member of the Metabolic and Autoimmune Practice at Health Advances.
Rita Sa Ferreira, PhD, is a Senior Analyst, Member of the Metabolics and Autoimmune Committee at Health Advances.