Semaglutide 1 mg demonstrated a statistically significant and superior reduction of 24% in the risk of kidney disease-related events vs. placebo in adults with type 2 diabetes and chronic kidney disease.
Based on FLOW trial data, Novo Nordisk submitted a label extension application for Ozempic®, which has been accepted for review by the FDA.
Novo Nordisk today presented the full results from FLOW, its phase 3b kidney outcomes trial investigating the effects of once-weekly injectable semaglutide 1 mg in adults with type 2 diabetes and chronic kidney disease (CKD), at the 84th Annual Scientific Sessions of the American Diabetes Association (ADA). The double-blind, randomized, placebo-controlled trial, which enrolled 3,533 people with type 2 diabetes and CKD, achieved its primary endpoint, with semaglutide 1 mg demonstrating a 24% reduction in the risk of kidney disease progression and cardiovascular and kidney mortality compared to placebo (331 vs. 410 events; hazard ratio: 0.76 [0.66; 0.88]; P=0.0003).1 The primary outcome was major kidney disease events, a composite of onset of kidney failure (initiation of long-term dialysis, kidney transplantation, or a reduction in the eGFR to <15 ml per minute per 1.73 m2 sustained for ?28 days), a sustained (for ?28 days) 50% or greater reduction in eGFR from baseline, or death from kidney-related or cardiovascular causes.
