Endocrinology Month in Review: February 2025

Credit: HCPLive

February was a month of significant developments in endocrinology, with notable updates in diabetes management and treatment efficacy. Monlunabant failed to meet its primary endpoint in a Phase 2 trial while promising one-year pilot study results suggested that CELZ-201 could significantly reduce insulin dependency and stabilize hemoglobin A1c (HbA1c) in type 2 diabetes (T2D). Meanwhile, a meta-analysis of over 600 trials highlighted how age and sex may influence the cardioprotective benefits of sodium-glucose co-transporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1 RAs).

A new analysis of the SCORED trial showed sotagliflozin lowered the risk of major adverse cardiovascular events (MACE) in individuals with both T2D and chronic kidney disease (CKD). The US Food and Drug Administration (FDA) officially declared an end to the semaglutide shortage, alleviating supply concerns that had driven increased reliance on compounded alternatives.

On the technology front, automated insulin delivery (AID) systems were a focal point of discussion, particularly in the latest episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives. Experts reviewed recent studies on the Omnipod 5 and MiniMed™ 780G systems, underscoring their impact on glycemic control in adults with T2D.

Here’s what happened in February:

Monlunabant Misses Primary Endpoint in Phase 2 Diabetic Kidney Disease Trial

According to a 2024 financial report, Novo Nordisk completed a Phase 2 trial of monlunabant, formerly INV-202, in patients with diabetic kidney disease. The trial investigated the efficacy and safety of a once-daily 10 mg and 25 mg dose of monlunabant, a small molecule oral cannabinoid receptor 1 (CB1) inverse agonist, in 254 people. At 16 weeks, monlunabant missed its primary endpoint for urine albumin-creatinine ratio (uACR) improvement compared with placebo.

Age May Modify Cardioprotective Effects of SGLT2 Inhibitors, GLP-1 RAs

Treatment with SGLT2 inhibitors and GLP-1 RAs was linked to a reduced risk of MACE in people with T2D, with interactions by age and sex. The meta-analysis of 601 trials found SGLT2 inhibitor use modestly reduced with increasing age, but a greater reduction in MACE in older cohorts. GLP-1 RA use showed some HbA1c lowering in older participants, but the benefit for MACE was more apparent in younger, female participants.

CELZ-201 Cuts Insulin Dependency at 1 Year in Patients with Type 2 Diabetes

Positive one-year efficacy and safety results from the CELZ-201 (AlloStem™) pilot study showed efficacy in reducing insulin dependency and stabilizing HbA1c in people with T2D. Creative Medical Technology reported an 80% overall efficacy rate in reducing insulin dependency and stabilizing HbA1c levels, with safety analysis linking no serious adverse effects to CELZ-201.

Sotagliflozin Cuts MACE Risk By 23% in Patients with Type 2 Diabetes, CKD

Sotagliflozin reduced the risk of MACE, including myocardial infarction and stroke, by approximately 23% in a recent analysis of patients with T2D and chronic kidney disease (CKD). This prespecified analysis of the SCORED trial randomized nearly 11,000 patients with additional cardiovascular risk to sotagliflozin, a dual sodium-glucose cotransporter (SGLT) 1/2 inhibitor, or placebo.

FDA Announces End to Shortage of Semaglutide Products (Ozempic, Wegovy)

The FDA declared a shortage of Novo Nordisk’s semaglutide injection (Ozempic) and semaglutide injection 2.4 mg (Wegovy) to be over, determining the US supply meets or exceeds current and expected demand. The popular GLP-1 RA medication experienced notable supply issues for the management of T2D and obesity or overweight, with a subsequent rise in compounding medications.

Diabetes Dialogue

Diabetes Dialogue: Omnipod 5 and Medtronic 780G for Type 2 Diabetes

In the last episode of our flagship endocrinology podcast, Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP assessed a pair of recently published studies examining the use of automated insulin delivery (AID) systems in adults with T2D. These studies included the SECURE-T2D trial evaluating the impact of Omnipod 5 AID on glycemic control and a 13-site single-arm study of the MiniMed™ 780G advanced hybrid closed-loop (AHCL) system.