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Beernink, J.M.* ; Heerspink, H.J.L.* ; Birkenfeld, A.L. ; Cherney, D.Z.I.* ; Colhoun, H.M.* ; Groop, P.* ; Ji, L.* ; Mathieu, C.* ; Rosas, S.E.* ; Tuttle, K.R.* ; Skyler, J.S.* ; Amor, A.J.* ; Caramori, M.L.* ; Fiorina, P.* ; Jongs, N.* ; Pagotto, U.* ; Setola, E.* ; Brinker, M.* ; Lawatscheck, R.* ; Russel, J.* ; Schloemer, P.* ; McGill, J.B.* ; Rossing, P.*

Effect of finerenone on albuminuria in type 1 diabetes by baseline HbA1c level and diabetes duration: An exploratory analysis of the FINE-ONE trial.

Diabetes Care 49, 1434-1441 (2026)
DOI PMC
OBJECTIVE To evaluate whether the efficacy and safety of finerenone varied by baseline hemoglobin A(1c) (HbA(1c)) level, a proxy of glycemic control, and diabetes duration in people with type 1 diabetes and chronic kidney disease (CKD). RESEARCH DESIGN AND METHODS Adults with type 1 diabetes, urinary albumin-to-creatinine ratio (UACR) 200 to <5,000 mg/g, and estimated glomerular filtration rate (eGFR) 25 to <90 mL/min/1.73 m(2) were randomly assigned (one to one) to finerenone or placebo. UACR change from baseline over 6 months by baseline HbA(1c) and diabetes duration was analyzed. RESULTS Baseline HbA(1c) was available for 240 of 242 participants; mean (SD) HbA(1c), diabetes duration, and eGFR were 7.6% (1.1%; 60 [12] mmol/mol), 32.0 (14.2) years, and 58.9 (19.2) mL/min/1.73 m(2), respectively. At 6 months, HbA(1c) (95% CI) remained unchanged (finerenone +0.03% [-0.14%, 0.20%]; placebo 0.00% [-0.12%, 0.11%]; between-group difference +0.04% [-0.17%, 0.24%]; P = 0.74). Over 6 months, median UACR decreased from 574.6 to 373.5 mg/g with finerenone and from 506.4 to 475.6 mg/g with placebo, corresponding to a -25% placebo-corrected change (95% CI -35%, -13%; P = 0.0001). Treatment effects were consistent across HbA(1c) tertiles (<7.1%, >= 7.1% to <= 8.1%, and >8.1%), with placebo-corrected UACR changes (95% CIs) of -17% (-40%, 13%), -18% (-39%, 10%), and -37% (-55%, -13%), respectively (P interaction = 0.41). Effects were similarly consistent across diabetes duration tertiles (P interaction = 0.70). Overall safety and incidence of hyperkalemia were similar across HbA(1c) tertiles. CONCLUSIONS In adults with type 1 diabetes and CKD, finerenone reduced UACR and was well tolerated irrespective of HbA(1c) level or diabetes duration.
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Publication type Article: Journal article
Document type Scientific Article
Keywords Kidney-disease; Excess Mortality; Nationwide; Microalbuminuria
ISSN (print) / ISBN 0149-5992
e-ISSN 1935-5548
Journal Diabetes Care
Quellenangaben Volume: 49, Issue: 8, Pages: 1434-1441 Article Number: , Supplement: ,
Publisher American Diabetes Association
Publishing Place Alexandria, Va.
Reviewing status Peer reviewed
Institute(s) Institute of Diabetes Research and Metabolic Diseases (IDM)
Grants Bayer AG