Diabetes Dialogue: Understanding Semaglutide (Ozempic) in CKD and T2D

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!

The US Food and Drug Administration (FDA) approval of semaglutide 1.0 (Ozempic) for reducing the risk of kidney disease progression in type 2 diabetes marks a significant advance in the treatment landscape.

The decision, which was announced on January 28, 2025, was based on the phase 3b FLOW trial, which showed semaglutide reduced the risk of kidney disease worsening, end-stage kidney disease, and cardiovascular death by 24% compared to placebo when added to standard of care (Hazard Ratio [HR], 0.76; 95% Confidence Interval [CI], 0.66 to 0.88; P = .0003).

The trial enrolled 3533 adults and was stopped early due to meeting efficacy criteria after a median follow-up of 3.4 years. Additional analyses showed a 21% risk reduction for kidney-specific events (HR, 0.79; 95% CI, 0.66 to 0.94), and a 29% reduction in cardiovascular death versus placebo (HR, 0.71; 95% CI, 0.56 to 0.89). In their announcement of the approval, Novo Nordisk noted that this approval makes semaglutide the most broadly indicated GLP-1 receptor agonist in its class.

To celebrate the approval and breakdown what the latest semaglutide approval means for clinicians and patients with type 2 diabetes, hosts 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, convened for a special edition episode of Diabetes Dialogue.

During the episode, hosts dive into the approved indication, supporting data from the FLOW trial, how the new indication might influence where semaglutide fits into treatment algorithms, and what type of potential semaglutide could have in populations with chronic kidney disease without type 2 diabetes.

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.