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UREX: Empagliflozin and Benzbromarone on Uric Acid Excretion
NCT05210517Phase 4
Key facts
- Status
- Completed
- Start
- Oct 2020
- Primary completion
- Jun 2021
- Countries
- 1
- Sponsor
- Amsterdam University Medical Center
- Modality
- Small Molecules
- Drugs
- empagliflozin
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 4, randomised, open-label trial of empagliflozin in type 2 diabetes mellitus (T2DM) (4 arms), sponsored by Amsterdam University Medical Center. Primary endpoints: plasma uric acid at 1 week and Fractional uric acid excretion at 1 week. Started Oct 2020; status: completed.
02
Design
4 arms- Study design
- RandomizedOpen-label
No intervention
No treatment arm
Empagliflozin
Empagliflozin 25 mg once daily for one week
Benzbromarone
Benzbromarone 100 mg once daily for one week
Empagliflozin-Benzbromarone
Empagliflozin 25 mg combined with Benzbromarone 100 mg once daily for one week
03
Who it enrols
Caucasian men or post-menopausal women with type 2 diabetes on stable metformin therapy, HbA1c 6.5-9.0%, and BMI > 25 kg/m2.
04
Endpoints
Primary
plasma uric acid
Fractional uric acid excretion
Secondary
urinary glucose
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