Diabetes Dialogue: FINE-ONE and Finerenone in Type 1 Diabetes at Kidney Week 2025

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

In this Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, 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, break down 1 of the most anticipated presentations from American Society of Nephrology (ASN) Kidney Week 2025: the FINE-ONE trial.

The first phase 3 study to evaluate finerenone for chronic kidney disease (CKD) in type 1 diabetes, FINE-ONE was a global, randomized, double-blind, placebo-controlled phase 3 trial enrolling 242 participants across 80 sites in 9 countries. Participants received once-daily finerenone (10 mg or 20 mg) or placebo, with dose based on eGFR and titration permitted at 30 days if potassium remained ≤4.8 mmol/L and eGFR decline was <30%. All participants continued optimized background therapy for BP, lipids, and glycemia; insulin regimens were unchanged.

At 6 months, finerenone achieved a 25% relative reduction in UACR vs placebo, meeting its primary endpoint. Investigators noted 68.1% of finerenone-treated patients reached a ≥30% UACR reduction, compared with 46.6% on placebo, which exceeded the ADA-recognized threshold linked with slower CKD progression. The safety profile for finerenone was consistent with prior trials in T2D, with no new hyperkalemia or cardiorenal signals.

Isaacs and Bellini emphasize the significance of having a non-glucose-lowering therapy with demonstrated renal benefit in type 1 diabetes in light of the limitations of SGLT2 inhibitors in this population due to euglycemic DKA risk.

Despite the encouraging findings, the hosts caution that the sample size is modest and the study was not powered for cardiovascular outcomes. They note an FDA indication will be critical for broad adoption, payer coverage, and field education, which are historically areas where type 1 diabetes therapies often lag.

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.

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