Impact of Simultaneous Initiation of Finerenone and Empagliflozin on Albuminuria Irrespective of Baseline HbA1c Levels: A Participant-Level Exploratory Analysis of the Randomised CONFIDENCE Trial

McGill JB, Green JB, Heerspink HJ, Mann JF, Mottl AK, Rosenstock J, Rossing P, Vaduganathan M, Nangaku M, Brinker M, Scott C, Rohwedder K, Li L, Li N, Seco M, Agarwal R (2026)

Publication Type: Journal article

Publication year: 2026

Journal

Diabetes Obesity & Metabolism Wiley-Blackwell

DOI: 10.1111/dom.70949

Abstract

Aims: This prespecified analysis evaluated whether the safety and efficacy of finerenone and a sodium–glucose cotransporter 2 inhibitor (SGLT2i) combination vary by baseline glycated haemoglobin (HbA1c). Materials and Methods: Adults with type 2 diabetes and a urinary albumin-to-creatinine ratio (UACR) of 100 − < 5000 mg/g, estimated glomerular filtration rate (eGFR) 30–90 mL/min/1.73 m2 and HbA1c < 11% (< 97 mmol/mol) were randomised (1:1:1) to once-daily finerenone, empagliflozin or combination. Primary outcome was UACR change from baseline at Day 180. Results: Baseline HbA1c was available for 781/800 CONFIDENCE participants; baseline HbA1c and eGFR mean values (standard deviation) were 7.3% (1.2%) and 54.2 mL/min/1.73 m2 (17.1 mL/min/1.73 m2). At Day 180, HbA1c decreased with combination therapy and empagliflozin (both least-squares mean change −0.1% [95% confidence interval −0.2, −0.0]), with no change with finerenone. In total, 212, 190, 188 and 191 participants were included in HbA1c Quartiles 1 (HbA1c ≤ 6.4% [≤ 46 mmol/mol]), 2 (HbA1c > 6.4 and ≤ 7.1% [> 46 and ≤ 54 mmol/mol]), 3 (HbA1c > 7.1 and ≤ 7.9% [> 54 and ≤ 63 mmol/mol]) and 4 (HbA1c > 7.9% [> 63 mmol/mol]), respectively. Change from baseline in HbA1c at Day 180 was greatest in Quartile 4. At Day 180, combination therapy reduced UACR from baseline in all HbA1c quartiles to a greater extent than either monotherapy (mean [95% CI] –53% [−63, −42], −47% [−57, −34], −63% [−70, −54] and −55% [−65, −42], in Quartiles 1–4, respectively). Conclusion: Simultaneous initiation with finerenone and an SGLT2i reduced UACR compared with monotherapy and was well-tolerated irrespective of HbA1c levels.

Involved external institutions

Veterans Health Administration (VHA) US United States (USA) (US) Washington University in St. Louis US United States (USA) (US) Brigham and Women's Hospital (BWH) US United States (USA) (US) Bayer AG DE Germany (DE) Bayer Corporation US United States (USA) (US) Bayer HealthCare AG DE Germany (DE) Duke University Health System US United States (USA) (US) University Medical Center Groningen (UMCG) / Universitair Medisch Centrum Groningen NL Netherlands (NL) University of North Carolina at Chapel Hill US United States (USA) (US) University of Texas Southwestern Medical Center (UT Southwestern) US United States (USA) (US) Steno Diabetes Center DK Denmark (DK)

How to cite

APA:

McGill, J.B., Green, J.B., Heerspink, H.J., Mann, J.F., Mottl, A.K., Rosenstock, J.,... Agarwal, R. (2026). Impact of Simultaneous Initiation of Finerenone and Empagliflozin on Albuminuria Irrespective of Baseline HbA1c Levels: A Participant-Level Exploratory Analysis of the Randomised CONFIDENCE Trial. Diabetes Obesity & Metabolism. https://doi.org/10.1111/dom.70949

MLA:

McGill, Janet B., et al. "Impact of Simultaneous Initiation of Finerenone and Empagliflozin on Albuminuria Irrespective of Baseline HbA1c Levels: A Participant-Level Exploratory Analysis of the Randomised CONFIDENCE Trial." Diabetes Obesity & Metabolism (2026).

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