by Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives
Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives is a podcast hosted by Drs. Diana Isaacs and Natalie Bellini aimed at providing a regular roundup of the latest clinically applicable insights across diabetes and metabolic diseases, with a focus on leveraging technology to improve care. A video version of each episode is available at http://HCPLive.com/Clinical/Endocrinology. Please direct podcast-related inquiries to [email protected]. Editor's note: Episodes predating January 2023 were hosted by Endocrinology Network. Episodes predating March 2022 were titled The Endocrine Outlook.
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April 30, 2025
<div> <a href="https://www.hcplive.com/view/diabetes-dialogue-semaglutide-for-mash-in-essence-trial-with-arun-sanyal-md">Video Version Only on HCPLive!</a><br> <br> In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, break down new Phase 3 data from the ESSENCE trial examining semaglutide 2.4 mg (Wegovy) for <a href="https://www.hcplive.com/clinical/mash-masld">metabolic dysfunction-associated steatohepatitis (MASH) </a>with stage 2 or 3 fibrosis.<br> <br> With results published in The New England Journal of Medicine, hosts are joined by first author Arun J. Sanyal, MD, director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at Virginia Commonwealth University, to discuss key takeaways from part 1 of the ESSENCE trial, semaglutide’s impact on liver outcomes and weight loss, and what the data could mean for the future of MASH treatment.<br> <br> <strong>ESSENCE</strong><br> Once-weekly semaglutide 2.4 mg significantly improved liver outcomes in patients with metabolic dysfunction–associated steatohepatitis (MASH) and stage 2 or 3 fibrosis, according to findings from the ESSENCE trial.<br> <br> In part 1 of the ongoing, double-blind, placebo-controlled trial, 800 patients were evaluated at 72 weeks for two primary endpoints: resolution of steatohepatitis without worsening fibrosis, and fibrosis improvement without worsening steatohepatitis. Spanning 253 sites in 37 countries, the full trial enrolled 1197 biopsy-confirmed patients between May 2021 and April 2023.<br> <br> At the interim analysis, semaglutide achieved both primary endpoints. Resolution of steatohepatitis without fibrosis worsening occurred in 62.9% of patients receiving semaglutide compared with 34.3% in the placebo group (difference, 28.7%; 95% CI, 21.1–36.2; P <.001). Reduction in fibrosis without worsening steatohepatitis was observed in 36.8% of the semaglutide group versus 22.4% with placebo (difference, 14.4%; 95% CI, 7.5–21.3; P <.001).<br> <br> Secondary outcomes showed combined resolution of steatohepatitis and fibrosis reduction in 32.7% of semaglutide-treated patients versus 16.1% with placebo (difference, 16.5 percentage points; P <.001). Patients on semaglutide also experienced a mean body weight reduction of 10.5% versus 2.0% in the placebo group (difference: −8.5%; P <.001).<br> <br> While semaglutide was linked to a slight improvement in bodily pain scores on the SF-36, the result did not reach prespecified statistical significance. Adverse events occurred in 86.3% of the semaglutide group and 79.7% of the placebo group, primarily gastrointestinal. Rates of serious adverse events were similar at 13.4% in both groups.<br> <br> Resmetirom (Rezdiffra) is the only US Food and Drug Administration (FDA)-approved treatment for noncirrhotic MASH. These findings position semaglutide as a potential future option, pending results from the full ESSENCE trial and regulatory review.<br> <br> Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.<br> <br> <strong>Key Episode Timestamps</strong><br> <strong>00:00:01</strong> Introduction and Participant Backgrounds<br> <strong>00:01:18</strong> Overview of MASH and Insulin Resistance<br> <strong>00:03:28</strong> Phase 2 and Phase 3 Trials of Semaglutide<br> <strong>00:07:23</strong> Significant Findings and Clinical Implications<br> <strong>00:09:44</strong> Challenges and Future Directions<br> <strong>00:14:50</strong> Mechanism of Action and Weight Loss<br> <strong>00:17:39</strong> Data on Weight Loss and Liver Improvement<br> <strong>00:20:42</strong> Potential for FDA Approval and Future Studies<br> <strong>00:25:04</strong> Conclusion and Final Thoughts</div>
April 29, 2025
<div> <a href="https://www.hcplive.com/view/diabetes-dialogue-catalyst-reveals-high-prevalence-of-hypercortisolism-in-t2d"><strong>Video Version Only on HCPLive!</strong></a><strong><br> </strong><br> In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, discuss the newly published findings from the CATALYST trial, a prospective, observational study establishing the prevalence of hypercortisolism among individuals with <a href="https://www.hcplive.com/clinical/type-2-diabetes">difficult-to-control type 2 diabetes (T2D)</a>.<br> <br> CATALYST enrolled 1057 adults with T2D and suboptimal glycemic control (HbA1c, 7.5–11.5%) despite treatment with ≥2 glucose-lowering agents. All participants underwent a 1-mg overnight dexamethasone suppression test (DST), and common confounders were excluded. Hypercortisolism—defined as a post-DST cortisol level >1.8 µg/dL—was identified in 23.8% of participants, with even higher rates among those with cardiac disease (33.3%) or on ≥3 antihypertensives (36.6%). Adrenal imaging revealed abnormalities in about one-third of affected individuals.<br> <br> Isaacs and Bellini emphasized how striking it is that such a high proportion of patients met criteria for hypercortisolism, a condition historically considered rare. The trial challenges that perception, revealing that clinical features like persistent hyperglycemia and hypertension—despite optimized therapy—could reflect underlying endocrine dysfunction. They noted that neither A1c nor body mass index (BMI) alone predicted elevated cortisol, although medication intensity and comorbid conditions did.<br> <br> The conversation explored how the recognition of hypercortisolism could alter clinical management. Future studies will assess whether targeted treatments—such as cortisol-lowering pharmacotherapy, including mifepristone (Korlym), or adrenal surgery—can reduce medication burden, improve glycemic control, and lower cardiovascular risk. Isaacs and Bellini pointed out that many patients with hypercortisolism present without the classic phenotype, underscoring the importance of broader screening criteria.<br> <br> Looking ahead, they called for greater awareness among clinicians to consider screening in patients on intensive diabetes and blood pressure regimens who still fail to reach therapeutic goals. Identifying and treating hypercortisolism could open a new pathway to improving outcomes in this population.<br> <br> Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.<br> <br> <strong>Key Episode Timestamps</strong><br> <strong>00:00:01</strong> Catalyst Trial Overview and Introduction<br> <strong>00:01:37 </strong>Patient Criteria and Initial Findings<br> <strong>00:04:18</strong> Implications and Next Steps<br> <strong>00:05:23</strong> Adrenal Imaging and Cardiac Disorders<br> <strong>00:07:22</strong> Clinical Implications and Future Research<br> <strong>00:09:13</strong> Demographic Differences and Future Directions</div>
April 24, 2025
<div> <a href="https://www.hcplive.com/view/diabetes-dialogue-oral-glp-1-orforglipron-in-achieve-1-trial">Video Version Only on HCPLive</a>!<br> <br> In this episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, discuss the top-line results from the ACHIEVE-1 trial evaluating orforglipron—an investigational, once-daily oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) developed by Eli Lilly—for adults with <a href="https://www.hcplive.com/clinical/type-2-diabetes">type 2 diabetes (T2D)</a> inadequately controlled by diet and exercise.<br> <br> Isaacs and Bellini emphasized the clinical significance of orforglipron’s Phase 3 data in the ACHIEVE-1 trial, which demonstrated substantial reductions in A1c (1.3–1.6%) from a baseline of 8.0% and notable weight loss averaging 16 pounds (7.9%) at the highest dose over 40 weeks. Impressively, more than 65% of participants achieved an A1c below 6.5%, meeting the American Diabetes Association (ADA)’s target for diabetes control.<br> <br> The hosts highlighted the convenience advantage of orforglipron compared to oral semaglutide, which has strict dosing requirements. Oral orforglipron can be taken without food or water restrictions, potentially increasing adherence and reducing treatment burden. They also noted the drug’s favorable safety profile, with gastrointestinal side effects similar in type and incidence to existing GLP-1 RAs, and no hepatic safety signals observed in the trial.<br> <br> Beyond glycemic control, Isaacs and Bellini discussed the broader implications for obesity treatment, pointing to the drug’s potential utility in weight management, pending regulatory submission. They explored the possibility of using injectable GLP-1 RAs for initial weight loss followed by oral maintenance with orforglipron—potentially lowering costs and improving access.<br> <br> The conversation touched on the upcoming ACHIEVE trial series, which will explore orforglipron in head-to-head comparisons with other agents, its use in insulin-treated T2D, and future indications including cardiovascular risk and kidney disease.<br> <br> While optimistic, the hosts stressed the need for cardiovascular outcomes data to confirm orforglipron’s safety and potential benefits in this domain. If confirmed, they suggested orforglipron could become a cornerstone oral therapy for T2D and obesity.<br> <br> Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.<br> <br> <strong>Key Episode Timestamps<br> </strong>00:00:01 Discussion on OR for GLP-1 Receptor Agonist<br> 00:02:13 Potential Impact and Patient Preferences<br> 00:03:59 Safety and Market Potential<br> 00:05:13 Cost and Transition Options<br> 00:06:32 Future Trials and Side Effects<br> 00:08:55 Cardiovascular Outcome Data and Conclusion</div>
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