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Optimization of Albuminuria-Lowering Therapies for Individual Patients with Type 2 Diabetes Using Empagliflozin and Finerenone in a Pilot Remote Clinical Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508585-15-00
Acronym
18253
Enrollment
10
Registered
2024-04-25
Start date
2024-07-29
Completion date
Unknown
Last updated
2024-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Albuminuria, Type 2 diabetes

Brief summary

Questionnaire results: participants’ perspectives toward the feasibility of participation in a trial at home with digital technologies, Number and percentage of urine collections not received at the laboratory or unable to be analyzed, Number and percentage of missed blood pressure or body weight measurements, Treatment adherence: pill count and medication concentration in urine samples

Detailed description

Change from baseline in UACR from start to end of treatment with empagliflozin, Change from baseline in systolic blood pressure, body weight, eGFR, and fasting plasma glucose from start to end of treatment with empagliflozin, (Additive) treatment effects on UACR, systolic blood pressure, body weight, eGFR, and fasting plasma glucose from start to end of treatment after the addition or substitution with finerenone

Interventions

DRUGJardiance 10 mg film-coated tablets

Sponsors

Universitair Medisch Centrum Groningen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Questionnaire results: participants’ perspectives toward the feasibility of participation in a trial at home with digital technologies, Number and percentage of urine collections not received at the laboratory or unable to be analyzed, Number and percentage of missed blood pressure or body weight measurements, Treatment adherence: pill count and medication concentration in urine samples

Secondary

MeasureTime frame
Change from baseline in UACR from start to end of treatment with empagliflozin, Change from baseline in systolic blood pressure, body weight, eGFR, and fasting plasma glucose from start to end of treatment with empagliflozin, (Additive) treatment effects on UACR, systolic blood pressure, body weight, eGFR, and fasting plasma glucose from start to end of treatment after the addition or substitution with finerenone

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026