Optimization of Albuminuria-Lowering Therapies for Individual Patients With Type 2 Diabetes Using Empagliflozin and Finerenone in a Pilot Remote Clinical Trial
Abstract
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)
Conditions: Diabetes Mellitus Type 2 With Proteinuria, Diabetes Mellitus, Type 2,…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 12 participants or records.
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