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

• Status: Not yet recruiting
• Trial end date: 2024-10-01

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)

• Phase: Phase 4

Details

• Lead Sponsor: University Medical Center Groningen
• Collaborator: Boehringer Ingelheim
• Treatments: Empagliflozin