EUROBEAT Study

JRCT ID: jRCTs051200147

Registered date:05/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus
• Date of first enrollment: 05/03/2021
• Target sample size: 80
• Study type: Interventional
• Intervention(s): The patients are assigned to empagliflozin treated or placebo treated group. In the patients of both groups, the agent is orally administered at the dose of 10 mg once daily. The patients are prohibited from taking additional other SGLT2 inhibitors by the end of the study or the study termination.

Outcome(s)

• Primary Outcome: Change from baseline in urinary albumin and L-FABP excretion

Secondary Outcome

Change from baseline in serum VEGF, adrenomedullin, ANGPTL2, and ANGPTL4
Change from baseline in urinary NGAL, and KIM-1

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

20 years old or older, less than 85 years old with type 2 diabetes mellitus HbA1c of 6.5% or higher, and less than 10.0%
Urinary albumin excretion of 30mg/gCr or higher, and less than 300mg/gCr, and eGFR more than 30ml/min/1.72m2
No change in internal use of renin-angiotensin system inhibitors within 3 months of consent
No change in internal use of hypoglycemic drugs within 3 months of consent

Exclude criteria

BMI less than 18.5 kg/m2
Patients who diagnosed as chronic glomerulonephritis
Patients who are /want to pregnant, or are breast feeding
Patients taking SGLT2 inhibitors within 3 months of consent
Patients with heart failure of NYHA III or IV New York Heart Association functional classification
Patients who diagnosed as acute coronary syndrome or stroke within 3 months of consent
Patients who performed PCI or CABG within 3 months of consent

Related Information

• Primary Sponsor: Makino Hisashi
• Secondary Sponsor: Nippon Boehringer Ingelheim Co ., Ltd.,Eli Lilly and Company