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Clinical Trial Details

Trial ID: L1513
Source ID: NCT06094920
Associated Drug: Empagliflozin 10 Mg
Title: Treatment Optimization for Patients With Type 2 Diabetes Using Empagliflozin and Finerenone in a Remote Clinical Trial
Acronym: Optimize@Home
Status: ENROLLING_BY_INVITATION
Study Results: NO
Results:
Conditions: Diabetes Mellitus Type 2 With Proteinuria|Diabetes Mellitus, Type 2|Diabetes Mellitus|Diabetes|Diabetes Complications|Albuminuria|Chronic Kidney Diseases|Chronic Kidney Disease Due to Type 2 Diabetes Mellitus|Chronic Kidney Disease stage3|Chronic Kidney Disease stage4|CKD|CKD Stage 3|CKD Stage 4
Interventions: DRUG: Empagliflozin 10 MG|DRUG: Finerenone|DEVICE: Withings BPM Connect|DEVICE: Withings Body|DIAGNOSTIC_TEST: PeeSpot Urine Collection Device|DIAGNOSTIC_TEST: Hem-Col Capillary Blood Collection Device|BEHAVIORAL: Questionnaire: participants' perspectives toward the feasibility of participation in a trial at home with digital technologies
Outcome Measures: Primary: Questionnaire results, Participants' perspectives toward the feasibility of participation in a trial at home with digital technologies, Will be assessed within 6 months and reported within 1 year after conclusion of the study.|Remote urine collection, Number and percentage of urine collections not received at the laboratory or unable to be analysed, Will be assessed within 6 months and reported within 1 year after conclusion of the study.|Remote blood pressure measurements, Number and percentage of missed blood pressure measurements, Will be assessed within 6 months and reported within 1 year after conclusion of the study.|Remote body weight measurements, Number and percentage of missed body weight measurements, Will be assessed within 6 months and reported within 1 year after conclusion of the study.|Treatment adherence, Pill count and medication concentration in urine samples, Will be assessed within 6 months and reported within 1 year after conclusion of the study. | Secondary: Individual UACR response to empagliflozin, Change from baseline in UACR from start to end of treatment with empagliflozin., Will be assessed within 6 months and reported within 1 year after conclusion of the study.|Individual systolic blood pressure response to empagliflozin, Change from baseline in systolic blood pressure from start to end of treatment with empagliflozin., Will be assessed within 6 months and reported within 1 year after conclusion of the study.|Individual body weight response to empagliflozin, Change from baseline in body weight from start to end of treatment with empagliflozin., Will be assessed within 6 months and reported within 1 year after conclusion of the study.|Individual eGFR response to empagliflozin, Change from baseline in eGFR from start to end of treatment with empagliflozin., Will be assessed within 6 months and reported within 1 year after conclusion of the study.|Individual fasting plasma glucose response to empagliflozin, Change from baseline in fasting plasma glucose from start to end of treatment with empagliflozin., Will be assessed within 6 months and reported within 1 year after conclusion of the study.|(Additive) treatment effects finerenone on UACR, (Additive) treatment effects on UACR from start to end of treatment after the addition or substitution with finerenone., Will be assessed within 6 months and reported within 1 year after conclusion of the study.|(Additive) treatment effects finerenone on systolic blood pressure, (Additive) treatment effects on systolic blood pressure from start to end of treatment after the addition or substitution with finerenone., Will be assessed within 6 months and reported within 1 year after conclusion of the study.|(Additive) treatment effects finerenone on body weight, (Additive) treatment effects on body weight from start to end of treatment after the addition or substitution with finerenone., Will be assessed within 6 months and reported within 1 year after conclusion of the study.|(Additive) treatment effects finerenone on eGFR, (Additive) treatment effects on eGFR from start to end of treatment after the addition or substitution with finerenone., Will be assessed within 6 months and reported within 1 year after conclusion of the study.|(Additive) treatment effects finerenone on fasting plasma glucose, (Additive) treatment effects on fasting plasma glucose from start to end of treatment after the addition or substitution with finerenone., Will be assessed within 6 months and reported within 1 year after conclusion of the study.
Sponsor/Collaborators: Sponsor: University Medical Center Groningen | Collaborators: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 10
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-05
Completion Date: 2025-10-30
Results First Posted:
Last Update Posted: 2025-04-22
Locations: ZorgGroep Twente, Almelo, Overijssel, 7609PP, Netherlands
URL: https://clinicaltrials.gov/show/NCT06094920