Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives! In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, explore 3 significant developments shaping diabetes care: a novel glucose-sensing technology, the return of once-weekly insulin icodec to the US Food and Drug Administration (FDA), and changes to Eli Lilly’s metabolic research pipeline. 00:00:01 Introduction 00:00:18 The Biolinq Shine 00:05:59 The Practicality of Monitoring Glucose 00:06:55 Wishlist for the Biolinq's Future 00:08:38 Insulin Icodec Resubmission 00:10:21 Benefits of Once-Weekly Insulin 00:14:00 International Success Stories 00:15:28 Eli Lilly Cancels Bimagrumab for T2D 00:18:36 Bimagrumab Still in Testing for Obesity 00:22:49 Outro

In this milestone 150th 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 co-director 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, reflect on three and a half years of transformation in diabetes care and the evolution of their podcast since its launch in early 2022. What began as a modest plan for monthly discussions rapidly expanded into a weekly forum driven by an ever-accelerating pace of clinical innovation and the hosts’ shared enthusiasm for translating emerging science into practice.

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives! In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, sit down with Bob Vigersky, MD, Chief Medical Officer of Medtronic Diabetes, to discuss major developments in diabetes technology, regulatory approvals, and the company’s future direction. 00:00:00 Introduction 00:00:27 Background of Bob Vigersky, MD 00:02:40 Updates from Medtronic Diabetes 00:08:02 The Instinct Sensor 00:10:20 Calibrating New Devices 00:12:27 Moving to Type 2 00:15:00 Bolusing with New Devices 00:17:39 Looking Down the Pipeline 00:22:07 Prescribing the MiniMed 00:35:45 Outro

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives! In this episode, cohosts 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 Hospital Diabetes and Metabolic Care Center, discuss the recently published results of the ATTAIN-1 and STEP UP clinical trials, both of which were presented at the European Association for the Study of Diabetes (EASD) 2025 Conference. 00:00:00 Introduction 00:00:32 ATTAIN-1 00:04:07 GLP-1s as a Daily Pill 00:08:20 Possible Lower GLP-1 Prices 00:09:03 STEP UP 00:11:41 Cardiovascular Protection with GLP-1s 00:12:48 GI Side Effects of Semaglutide 7.2 00:16:16 3 Times the Dose, 3 Times the Cardiovascular Protection? 00:17:20 Outro

At ESC 2025, a pair of presentations highlighted the ongoing debate over cardiovascular risk reduction with semaglutide (Ozempic/Wegovy) and tirzepatide (Mounjaro/Zepbound), yielding conflicting signals that clinicians will need to interpret carefully. In this special edition episode, cohosts 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, explore these studies: SURMOUNT-5 and STEER. A post hoc analysis of SURMOUNT-5 compared the 10-year predicted CV risk reduction between the 2 agents. Using the Framingham Risk Calculator in 751 patients with obesity, tirzepatide was associated with greater benefit than semaglutide. From baseline risks of ~9%, tirzepatide was projected to lower absolute 10-year CV risk by 2.4% (23% relative reduction) compared with 1.4% (13% relative reduction) for semaglutide. Investigators attributed the advantage largely to greater weight and glycemic reductions. In contrast, the STEER study, a real-world analysis of more than 21,000 patients with a mean follow-up of 8.5 months, suggested semaglutide was associated with lower rates of major adverse cardiovascular events (MACE) than tirzepatide. Semaglutide users had a 29% risk reduction in nonfatal MI, nonfatal stroke, or CV death compared with tirzepatide. Limitations included short follow-up, relatively few CV events, and the inherent confounding of observational data. Both Isaacs and Bellini emphasized that while weight and glycemic improvements with tirzepatide appear robust, CV benefits may be molecule-specific. The ongoing SURPASS-CVOT, comparing tirzepatide with dulaglutide, should provide more clarity when full data are released at EASD. In the interim, the hosts advised prescribing based on labeled indications supported by randomized outcomes data—semaglutide for CV and kidney risk reduction, tirzepatide for obesity and sleep apnea—while awaiting definitive trial results. 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. References: Mamas M. SURMOUNT-5: Tirzepatide compared to Semaglutide in obesity for 10-year CVD risk reduction .Presented at the European Society of Cardiology (ESC) Congress 2025. Madrid, Spain. August 29- September 1, 2025. Novo Nordisk. Novo Nordisk’s Wegovy® cuts risk of heart attack, stroke or death by 57% compared to tirzepatide in real-world study of people with obesity and cardiovascular disease. Novo Nordisk. Published August 31, 2025. Accessed September 5, 2025. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916422

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives! In this episode, cohosts 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, explore the latest milestone for semaglutide (Wegovy): US Food and Drug Administration (FDA) approval for the treatment of metabolic dysfunction–associated steatohepatitis (MASH) with moderate to advanced fibrosis. They frame the decision as a breakthrough in addressing a disease that affects an estimated 6% of the U.S. population, with even higher prevalence among individuals with type 2 diabetes and obesity. MASH, often underrecognized and asymptomatic in its early stages, carries serious long-term consequences, including cirrhosis, hepatocellular carcinoma, liver transplantation, and premature mortality. 00:00:00 Introduction 00:00:32 Semaglutide (Wegovy) Approval 00:06:31 Novo Nordisk Announces Ozempic Price Change 00:08:21 Compounding Pharmacies 00:10:57 The Future of Semaglutide

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives! In this episode, 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, shared highlights on several major insulin delivery updates making waves at recent meetings. 00:00:00 Introduction 00:00:20 Pivot by Modular Medical 00:07:13 Medtronic's Partnership with Abbott - the Instinct Sensor 00:09:04 Tandem's One-Handed Insert 00:10:14 Tandem's Mobi Patch Pump

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives! In this episode, 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, highlight key advancements in diabetes management, particularly in continuous glucose monitoring (CGM) during pregnancy and the anticipated future of continuous ketone monitoring, from Association of Diabetes Care and Education Specialists (ADCES) 2025 annual meeting. 00:00:00 Introduction 00:00:30 Continuous Glucose Monitoring in Pregnancy 00:04:59 Stello versus Finger Sticks for Insulin Dosing 00:13:43 Innovative Presentations at ADCES 00:14:36 Ketone Monitoring 00:18:15 Product Theaters and Gamification at ADCES

In this episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, share key insights and takeaways from the Association of Diabetes Care and Education Specialists (ADCES) 2025 annual meeting. 00:00:00 Introduction 00:00:25 Orforglipron and the ATTAIN-1 study 00:01:29 Why orforglipron is exciting 00:04:21 ADCES - Incredible Incretins 00:10:33 ADCES - AI in diabetes management 00:12:59 New AI tools for endocrinology 00:19:01 ADCES - Implicit bias 00:21:30 Closing

On July 31, 2025, Eli Lilly and Company announced topline data from the SURPASS‑CVOT trial comparing tirzepatide (Mounjaro) to dulaglutide (Trulicity) in adults with type 2 diabetes and established atherosclerotic cardiovascular disease (ASCVD). According to the data, tirzepatide met the primary non‑inferiority endpoint for 3-point major adverse cardiovascular events (MACE) (hazard ratio [HR], 0.92; 95.3% CI, 0.83 to 1.01), while also showing additional benefits in A1C, weight reduction, renal preservation, and a 16% reduction in all‑cause mortality (HR, 0.84; 95.0% CI, 0.75 to 0.94). In the latest episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director 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, unpacked the top-line results of the SURPASS-CVOT trial. Eli Lilly and Company owns both drugs, which belong to the incretin class, but tirzepatide is a dual GIP/GLP-1 receptor agonist, while dulaglutide is a GLP-1 RA. The trial included over 13,000 adults with type 2 diabetes and either established cardiovascular disease or at high risk. During a median follow-up of 4.5 years, the primary endpoint, which was a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, was reduced by 8% in the tirzepatide group relative to dulaglutide. However, the result did not reach statistical superiority due to the confidence interval crossing unity. Isaacs and Bellini also highlighted significantly greater A1c (-1.73% vs -0.9%) and weight loss (12% vs 4.95%) with tirzepatide. Additional prespecified analyses comparing data with the placebo-controlled REWIND trial suggest tirzepatide could offer up to 28% MACE and 39% mortality risk reduction compared to theoretical placebo—findings that hint at broader cardiometabolic benefit. Before concluding, hosts speculated about the potential subgroup analyses of interest for the trial, including heart failure and renal outcomes, as well as a brief discussion around Eli Lilly and Company’s intent to submit a regulatory application for a cardiovascular indication before the close of 2025. 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. References: Eli Lilly and Company. Lilly's Mounjaro (tirzepatide), a GIP/GLP-1 dual agonist, demonstrated cardiovascular protection in landmark head-to-head trial, reinforcing its benefit in patients with type 2 diabetes and heart disease. July 31, 2025. Accessed July 31, 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-mounjaro-tirzepatide-gipglp-1-dual-agonist-demonstrated

Welcome back to Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives! In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the newly released Preexisting Diabetes in Pregnancy guidelines from The Journal of Clinical Endocrinology & Metabolism, which offer 10 key recommendations to improve outcomes in pregnant individuals with type 1 or type 2 diabetes. 00:00:00 Intro 00:01:25 Recommendations 1 and 2 00:02:27 Recommendation 3 00:07:11 Recommendation 4 00:09:58 Recommendation 5 00:14:51 Recommendations 6 and 7 00:19:05 Recommendation 8 00:23:11 Recommendation 9 00:25:11 Recommendation 10

Welcome back to Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives! In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director 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, recapped highlights from the 2025 Endocrine Society annual meeting. They spotlighted advances, controversies, and ongoing unmet needs in type 1 diabetes care. 00:00:00 Intro 00:00:40 GLP-1 RAs in type 1 diabetes 00:05:50 Tirzepatide in type 1 diabetes 00:08:32 Cardioprotective therapies in type 1 diabetes 00:12:17 Type 1 diabetes Barbie and public education

In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director 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, sit down with Carol Levy, MD, director of the Mount Sinai Diabetes Center and Type 1 Diabetes Clinical Research, to discuss the upcoming T1D Pregnancy and Me – or PRAM T1D – clinical study. Enrollment for T1D Pregnancy & Me is currently open. Interested listeners can enroll at https://www.mountsinai.org/clinical-trials/t1d-pregnancy-me. 00:00:00 Introduction 00:01:43 The "why" behind the trial 00:04:24 The structure of the study 00:07:37 Will maternal outcomes be collected? 00:08:12 Can patients enroll themselves in this trial? 00:12:40 No devices will be excluded 00:15:20 Dividing data based on first versus later pregnancies 00:18:14 Will you continue to enroll after the first 500?

In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director 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, continue their recap of ADA’s 2025 Scientific Sessions, spotlighting 3 more of the top clinical trials focused on obesity and type 2 diabetes. 00:00:00 Intro 00:00:31 BELIEVE Trial 00:08:11 Phase 2 Maritide Trial 00:17:12 CATALYST-2

In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director 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, recap some of the biggest clinical trials presented at the American Diabetes Association (ADA) 2025 conference in Chicago, Illinois. 00:00 Introduction 2:04 The Vertex Trial 6:57 The T1D Trial 15:23 The Achieve 1 Trial

In this episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, recorded during the 85th Scientific Sessions of the American Diabetes Association (ADA 2025) in Chicago, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, speak with Rachael Sood, RN, MSN, APRN, NP, CDCES, founder of The Diabetes Collective, about modern approaches to diabetes care, patient engagement, and the role of social media in education and advocacy. The discussion highlights Sood’s innovative use of social media to make diabetes education accessible and engaging. Known for creative and widely shared content—such as her wedding-themed video announcing the Dexcom G7 and Omnipod 5 integration—Sood shares how spontaneous, relatable messaging can improve awareness and patient connection. Her content spans emerging therapeutics like GLP-1 receptor agonists, type 1 diabetes staging and screening, and technology updates such as ketone monitoring and CGM integration. Sood reflects on the emotional impact of recent ADA presentations, including advances in islet cell therapy and the evolving treatment landscape for both type 1 and type 2 diabetes. She emphasizes the importance of healthcare providers offering clear, empathetic, and tailored care, recounting a patient case where basic interventions—CGM use, education, and therapeutic escalation—had a transformative effect after years of clinical inertia. The episode underscores the value of clinician-led care, continuity, and communication, particularly in independent practices. Sood also points to the importance of collaborative energy within the diabetes community, noting the power of partnerships among healthcare professionals, patients, and advocacy groups to drive progress. 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, Sanofi, and others. Sood has no relevant disclosures to report.

In this episode of Diabetes Dialogue, recorded live at the 85th Scientific Sessions of the American Diabetes Association (ADA 2025), hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, welcome Jay Shubrook, DO, and Conan Tu, MD, to explore the mission and momentum of the American College of Diabetology. The conversation centers on addressing the national shortage of diabetes specialists. Shubrook, a primary care diabetologist and founding figure in diabetology training, details the evolution of fellowship programs dating back to 2004, with the current infrastructure supporting 11 programs and plans for further expansion. Tu, an internist from New York, shares his personal journey into diabetology, emphasizing the increasing demand for diabetes-focused care in primary settings and the transformative impact of timely, expert-level interventions. The guests outline how the American College of Diabetology is building a standardized, certified workforce through board certification, with an emphasis on team-based care. The College is also actively expanding to include pharmacists, nurse practitioners, and other healthcare professionals in its educational and certification efforts, helping to equip interdisciplinary teams to manage diabetes more effectively. Additional discussion highlights include the importance of continuity of care—particularly during the transition from pediatric to adult diabetes services—the integration of cardiometabolic risk management, and the critical need for scalable models of care. The speakers advocate for diabetologists to serve not only as direct providers but as in-house experts, mentors, and system-level educators capable of elevating care across large networks. Learn more about the American College of Diabetology. 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, Sanofi, and others. Relevant dislcures for Tu include AstraZeneca, Eli Lilly and Company, and Optum. Relevant disclosures for Shubrook include Abbott, AstraZeneca, Bayer, Eli Lilly and Company, and Novo Nordisk.

In this episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, speak with John Buse, MD, PhD, of the University of North Carolina School of Medicine, about the treatment phase of the CATALYST trial. Findings from the phase 4 CATALYST trial suggest that mifepristone (Korlym), a glucocorticoid receptor antagonist, significantly improves glycemic control, reduces body weight, and lowers waist circumference in patients with hypercortisolism and difficult-to-control type 2 diabetes—offering a promising therapeutic option for a population with limited treatment success. The two-part, multicenter study enrolled 1055 adults with type 2 diabetes and HbA1c >7.5% despite optimized therapy. In part 1, participants underwent dexamethasone suppression testing to identify hypercortisolism, defined by post-test cortisol levels >1.8 µg/dL and dexamethasone >140 ng/dL. Results revealed a 24% prevalence of hypercortisolism in this population (95% CI, 21.4–26.7%). Part 2 randomized 136 patients with confirmed hypercortisolism in a 2:1 ratio to receive mifepristone or placebo for 24 weeks. The primary endpoint was change in HbA1c. Mifepristone treatment led to a least squares mean HbA1c reduction of 1.3 percentage points compared to placebo (95% CI, –1.81 to –0.83; P < .001). Secondary endpoints also favored mifepristone: body weight decreased by 5.12 kg (95% CI, –8.20 to –2.03), and waist circumference dropped by 5.1 cm (95% CI, –8.23 to –1.99) relative to placebo. Despite its efficacy, 49% of mifepristone-treated patients discontinued therapy, compared to 18% on placebo. Adverse events included hypokalemia, fatigue, nausea, vomiting, and elevated blood pressure, consistent with the drug’s known safety profile. During the episode, which was recorded during the 85th Scientific Sessions of the American Diabetes Association (ADA 2025), Buse provides hosts with a deep dive into the background of the trial, prevalence of hypercortisolism in difficult-to-control type 2 diabetes, and the historic relevance of the CATALYST results. Buse also discusses how the trial offers insight into dosing approaches with mifepristone and advocates for broader cortisol screening in patients with complex type 2 diabetes—suggesting that ADA Standards of Care should reflect these findings. 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. Relevant disclosures for Buse include Altimmune, AstraZeneca, Boehringer-Ingelheim, CeQur, Corcept Therapeutics, Eli Lilly, embecta, Moderna, Novo Nordisk, Tandem, Vertex, and others.

In this special episode recorded at 85th Scientific Sessions of the American Diabetes Association (ADA 2025), hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director 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, welcome Kevin Sayer, chief executive officer of Dexcom, for a candid conversation about the evolving landscape of continuous glucose monitoring (CGM). From Dexcom’s origins to the latest updates on G7 and the emerging Stelo app, the discussion traces the company's journey and innovation roadmap. Sayer reflects on how sharing real-time glucose data transformed the diabetes management experience—making life safer not just for children but also for adults living independently, caregivers, and entire family networks. Dexcom’s emphasis on data transparency has laid the groundwork for a broader shift toward individualized care, especially for those with type 2 diabetes. The episode dives into Dexcom’s growing footprint in type 2 diabetes management, with expanded coverage across the nation’s three largest pharmacy benefit managers. Sayer emphasizes that CGM is not just about preventing hypoglycemia in insulin users anymore—it’s a behavioral and educational tool. Patients can now “see” the impact of food choices, physical activity, and medication adherence in real time, prompting lifestyle changes that might otherwise take years of trial-and-error clinical encounters. The hosts also explore the integration of AI-powered features like food recognition, enhancements in the Stelo app for wellness tracking, and the implications of new CGM algorithms as G7 expands to 15-day wear. Sayer addresses the unique needs of people with and without diabetes and the regulatory constraints in tailoring CGM algorithms to specific use cases. In a lighter moment, Sayer shares his enthusiasm for Dexcom’s public-facing campaigns, including recent collaborations with Lance Bass and Nick Jonas as well as the company’s network of “Dexcom Warriors.” 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.

In this special episode recorded at 85th Scientific Sessions of the American Diabetes Association (ADA 2025), hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director 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, take a deep dive into the REDEFINE 1 and REDEFINE 2 trials with trial investigators W. Timothy Garvey, MD, of University of Alabama at Birmingham, and Melanie Davies, MD, of the University of Leicester. REDEFINE 1 was a 68-week, phase 3a trial enrolling over 3400 adults without diabetes but with obesity or overweight and at least one comorbidity. Participants received once-weekly CagriSema, semaglutide alone, cagrilintide alone, or placebo alongside lifestyle intervention. Key outcome: CagriSema led to a mean weight loss of 20.4%, vs 3.0% with placebo. Over 50% of participants on CagriSema reached a non-obese BMI. Gastrointestinal side effects were common (80%), but mostly mild to moderate. REDEFINE 2 enrolled 1206 adults with type 2 diabetes and overweight or obesity, randomized to CagriSema or placebo for 68 weeks. Key outcome: CagriSema led to 13.7% mean weight loss, vs 3.4% with placebo. 73.5% achieved an HbA1c ≤6.5% vs 15.9% on placebo. Significant improvements were seen across all weight loss and glycemic endpoints. The speakers also highlight the agent’s favorable side effect profile, flexibility in real-world dosing, and benefits in body composition and physical function. Garvey emphasizes the shift toward complication-centric obesity care, underscoring the need for clinician-guided treatment beyond online prescription models. The conversation closes with a look ahead to REDEFINE 3—a cardiovascular outcomes trial including patients with and without diabetes—and other ongoing studies in the REDEFINE and REIMAGINE trial programs. 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. Relevant disclosures for Garvey include Boehringer-Ingelheim, Novo Nordisk, Eli Lilly and Company, Merck & Co., Inc., Alnylam Pharmaceuticals, Inc., Fractyl Health, Inc., Inogen, Epitomee, Pfizer Inc., and Neurovalens. Relevant disclosures for Davies include Abbie, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, GSK, Novo Nordisk, Pfizer, Regeneron, Roche, Sanofi, and Zealand Pharma. References: Garvey WT, Blüher M, Osorto Contreras CK, et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. The New England Journal of Medicine. Published online June 22, 2025. doi: 10.1056/NEJMoa2502081 Davies MJ, Bajaj HS, Broholm C. Cagrilintide–Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes. The New England Journal of Medicine. Published online June 22, 2025. doi: 10.1056/NEJMoa2502082