Presentation at the American Diabetes Association
Results from the FLOW trial were presented at the 84th Annual Scientific Sessions of the American Diabetes Association, highlighting significant findings in diabetes and kidney disease treatment.
Prevalence of Diabetes and Kidney Disease
According to Diabetes UK, out of the 5.6 million people living with diabetes in the UK, 90% have type 2 diabetes (T2D). Approximately 40% of people with T2D will eventually develop chronic kidney disease (CKD), a condition that affects more than 800 million people worldwide.
Trial Overview
Previously presented at the 61st European Renal Association Congress and published in the New England Journal of Medicine, the FLOW trial compared once-weekly 1mg injectable Ozempic with a placebo. The study focused on kidney outcomes, assessing the risk reduction in the progression of kidney impairment, kidney and cardiovascular mortality in 3,533 people with T2D and CKD.
Ozempic’s Role and Indications
Indicated along with diet and exercise, Ozempic injection is a once-weekly glucagon-like peptide-1 receptor (GLP-1) agonist that helps improve blood sugar levels in adults with T2D and reduce cardiovascular events in adults with T2D who have known heart disease.
Key Findings from the FLOW Trial
Risk Reduction and Efficacy
Results demonstrated a 24% reduction in the risk of kidney disease progression and cardiovascular and kidney mortality compared to placebo. Ozempic 1mg showed superiority to placebo for all secondary outcomes assessed, including a significant reduction in the mean annual glomerular filtration rate.
Cardiovascular and Mortality Benefits
The risk of major cardiovascular events and the risk of death were significantly lower in the Ozempic group, with fewer serious adverse events reported compared to the placebo group.
Study Conclusion and FDA Review
After a median follow-up of just over three years, Novo Nordisk stopped the FLOW study due to the efficacy of Ozempic in preventing kidney disease-related incidences. Novo submitted a label extension application, which was accepted for review by the US Food and Drug Administration, with a decision anticipated in January 2025.
Expert Commentary
Anna Windle, senior vice president, clinical development, medical and regulatory affairs at Novo, commented: “The results from the FLOW trial represent important data as we look to better understand what GLP-1 treatment options could mean for this patient population.”