Endocrinology Year in Review: 2024

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Key Takeaways

The introduction of generic liraglutide marks a milestone as the first generic GLP-1 receptor agonist, potentially impacting diabetes treatment costs and accessibility.
Semaglutide's FDA label expansion for cardiovascular risk reduction in obesity and cardiovascular disease represents a significant advancement in weight loss medication.
The FDA's clearance of the Dexcom Stelo sensor as the first OTC CGM offers new monitoring options for non-insulin users, enhancing diabetes management flexibility.
Tirzepatide demonstrated superior weight loss efficacy over semaglutide in the SURMOUNT-5 trial, highlighting its potential in obesity management.
The CATALYST trial identified a higher-than-expected prevalence of hypercortisolism in type 2 diabetes, suggesting a need for increased screening and management.

A list recapping our most popular endocrinology coverage from the past year.

The past year in endocrinology and diabetes management has been marked by significant breakthroughs, advancements, and evolving standards of care. From groundbreaking approvals to pivotal clinical trial results, the field continues to evolve rapidly, offering new hope and improved treatment options for patients worldwide. Clinicians have witnessed a series of developments that may shape the future of diabetes management and endocrine care for years to come.

In this article, we spotlight the 10 most viewed pieces of news in endocrinology and diabetes management from 2024. This curated list includes trial updates, major regulatory decisions, guidelines, and more, with each having a profound effect on how healthcare providers approach the treatment of diabetes and related endocrine disorders. For deeper insights, we’ve also included links to related coverage from HCPLive.

Endocrinology Year in Review: 2024

Generic Liraglutide (Victoza) Becomes First Generic GLP-1 Receptor Agonist

On June 24, 2024, Teva Pharmaceuticals announced the launch of an authorized generic of liraglutide (Victoza) in the United States for the treatment of type 2 diabetes. According to the company, this marked the first-ever generic glucagon-like peptide-1 (GLP-1) receptor agonist.

Liraglutide, originally approved by the FDA in 2010, has also been shown to reduce the risk of major cardiovascular events in patients with type 2 diabetes and established cardiovascular disease. Teva’s generic version follows a settlement with Novo Nordisk, with liraglutide having generated annual sales of $1.656 billion as of April 2024.

Semaglutide (Wegovy) Receives FDA Label Expansion to Include Cardiovascular Risk Reduction

On March 8, 2024, the FDA approved an expanded label indication for semaglutide 2.4 mg (Wegovy) to reduce the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and obesity or overweight. This approval marks the first time a weight loss medication has been approved for cardiovascular risk reduction in this patient population.

The approval is based on data from the SELECT trial, a 17,604-patient study that demonstrated a 20% relative reduction in the risk of the primary cardiovascular events (HR, 0.80; P <.001) in patients receiving semaglutide compared to placebo. Additionally, semaglutide was associated with a mean body weight reduction of 9.39% versus 0.88% for placebo. Further analysis also suggested trends towards benefits in reducing cardiovascular death, heart failure hospitalization, and all-cause mortality.

FDA Clears Dexcom Stelo Sensor, First OTC Glucose Sensor in Agency History

On March 5, 2024, the US Food and Drug Administration (FDA) granted clearance for the Dexcom Stelo Glucose Biosensor System, the first over-the-counter continuous glucose monitor (CGM) in history. This decision follows Dexcom's application submission in Q4 2023, with plans for product launch in Summer 2024. The Stelo system, designed for individuals aged 18 and older who do not use insulin, will allow users to monitor their blood glucose levels without the involvement of a healthcare provider. It is particularly suited for those managing diabetes with oral medications or those without diabetes who wish to track how diet and exercise affect their blood sugar. The Stelo system is intended for use with non-insulin users, though it does not provide alerts for hypoglycemia.

Diabetes Dialogue: What to Know about Sequel Med Tech's twiist AID System, with Alan Lotvin, MD

In our most popular episode of Diabetes Dialogue: technology, Therapeutic, and Real-World Perspectives from 2024, Alan Lotvin, MD, chief executive officer and co-founder Sequel Med Tech. joins 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, for a deep dive into the latest AID to receive approval, including the pump’s patient-centric design, why they chose to leverage the Tidepool Loop algorithm, plans for device launch, and more.

SURMOUNT-5: Tirzepatide Bests Semaglutide in Head-to-Head Weight Loss Trial

On December 4, 2024, Eli Lilly and Company announced the results of the SURMOUNT-5 trial, showing that tirzepatide (Zepbound) outperforms semaglutide 2.4 mg (Wegovy) in weight loss. At 72 weeks, patients using tirzepatide experienced a 20.2% mean body weight reduction, compared to a 13.7% reduction with semaglutide, a 47% greater relative weight loss.

Tirzepatide also surpassed semaglutide in five key secondary endpoints. The trial, involving 751 adults with obesity or overweight and at least one comorbidity, demonstrated that 31.6% of tirzepatide users achieved a 25% body weight reduction, compared to 16.1% with semaglutide.

FDA Issues Complete Response Letter for Once-Weekly Insulin Icodec

On July 10, 2024, Novo Nordisk announced the receipt of a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its once-weekly basal insulin icodec, intended for the treatment of diabetes mellitus.

The CRL raised concerns regarding the manufacturing process and the type 1 diabetes indication, which must be addressed before the Biologics License Application (BLA) review can proceed. Novo Nordisk intends to review the requests and work with the FDA but does not expect to fulfill these requests in 2024. The ONWARDS clinical program, which supported the BLA, demonstrated positive results for insulin icodec in type 2 diabetes, but data for type 1 diabetes were considered insufficient by the FDA's Advisory Committee in May 2024. Insulin icodec is approved in several countries, including the EU and Canada, for type 1 diabetes and type 2 diabetes.

What to Know About Cannabis Use and Diabetes, with Halis Akturk, MD

As part of our coverage of the 84th American Diabetes association Scientific Sessions, HCPLive conducted a bevy of interviews with leading subject matter experts, including Halis Akturk, MD, associate professor of medicine and pediatrics at the Barbara Davis Center for Diabetes at the University of Colorado, who led a session titled “The Highs and Lows of Cannabis Use in Diabetes—Behavioral and Psychosocial Considerations”.

In this interview from the conference floor, Akturk discusses what additional risks are associated with cannabis use in adults with and without type 1 diabetes and what questions he hears most often from his colleagues regarding the topic.

FDA Approves Tirzepatide for Obstructive Sleep Apnea in Obesity

On December 20, 2024, Eli Lilly announced the FDA approval of tirzepatide (Zepbound) for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. This dual GIP/GLP-1 agonist demonstrated up to 20% weight loss and a reduction of ≥25 breathing interruptions per hour during sleep in the SURMOUNT-OSA trial.

In patients without positive airway pressure (PAP) therapy, tirzepatide reduced breathing disruptions by 25 hourly events compared to 5 for placebo, with similar outcomes in those using PAP therapy. Nearly 50% of tirzepatide-treated patients achieved remission or mild, non-symptomatic OSA.

CATALYST Proves Hypercortisolism More Common than Previously Known in Type 2 Diabetes

On June 24, 2024, data from the CATALYST trial, presented at the 84th American Diabetes Association (ADA) Scientific Sessions, revealed that hypercortisolism is present in 24% of patients with difficult-to-control type 2 diabetes, with prevalence increasing to 33% among those on three or more antihypertensive agents. The trial, the largest of its kind, suggests that over 1 million US adults with difficult-to-control type 2 diabetes may have undiagnosed hypercortisolism. Lead investigator John Buse, MD, PhD, expressed surprise at the finding, noting that the original estimate was only 8%. The first phase of the trial screened 1,000 patients and found that 253 met the criteria for hypercortisolism. Patients with hypercortisolism were older, more likely to be non-Hispanic or Latino, and had higher medication burdens. Data from the second phase of the trial, which is evaluating the efficacy of mifepristone (Korlym) in treating hypercortisolism in these patients, was announced in December 2024.

FDA Clears Omnipod 5 AID System for Type 2 Diabetes

results from the SECURE-T2D trial, presented at the 84th American Diabetes Association Scientific Sessions, showed that the Omnipod 5 automated insulin delivery (AID) system reduced median HbA1c from 8.2% to 7.4% over 13 weeks among users with type 2 diabetes. The trial, the largest and most racially diverse study of AID in this population, demonstrated significant benefits, including a nearly 5-hour increase in time in range per day, with consistent results across various subgroups.

The study enrolled 305 participants with a mean age of 57 years and a median diabetes duration of 17 years. At baseline, 62% were using CGM, and 25% had never used CGM. Improvements included a 20% increase in time in range (70 to 180 mg/dL) and a 20% reduction in time above 180 mg/dL, driven by reductions in hyperglycemia without increased hypoglycemia. After the 13-week period, 90% of participants said they would recommend Omnipod 5, and 78% expressed interest in continuing its use.