Treatment Optimization for Patients With Type 2 Diabetes Using Empagliflozin and Finerenone in a Remote Clinical Trial

Summary

The goal of this clinical trial is to determine the feasibility of remote clinical trial conduct in patients with type 2 diabetes and elevated albuminuria. The main questions it aims to answer are: * What is the feasibility (and advantages) of remote clinical trial conduct with multiple medications in patients with type 2 diabetes and elevated albuminuria? * What is the individual response to the SGLT2 inhibitor empagliflozin in urine albumin-creatinine ratio? * What is the individual response to the SGLT2 inhibitor empagliflozin in systolic blood pressure, body weight, eGFR, and fasting plasma glucose? * Can suboptimal treatment responses to empagliflozin be overcome by the addition or substitution with finerenone? Participants will collect all study data in the comfort of their own environments * First-morning void urine samples * Capillary blood samples * Blood pressure * Body weight Participants will be assigned to a 3-week treatment period with empagliflozin 10 mg/day. Based on the albuminuria response after 2 weeks, participants will be allocated to one of three treatment regimens after the 3-week treatment period with empagliflozin: * Continue empagliflozin for 4 more weeks (good response). * Continue empagliflozin for 4 more weeks and add finerenone 10 or 20 mg will be added for 4 weeks (moderate response). * Stop empagliflozin and start finerenone 10 or 20 mg for 4 weeks (no response)

Timeline

Start

2024-07-29

Primary completion

2025-09-24

Completion

2025-09-24

Drugs

Indications