EUROBEAT Study

Phase 4

• Conditions: Type 2 diabetes mellitus

• Registration Number: JPRN-jRCTs051200147
• Lead Sponsor: Makino Hisashi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-05
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in urinary albumin and L-FABP excretion

Secondary Outcome Measures

Name	Time	Method
Change from baseline in serum VEGF, adrenomedullin, ANGPTL2, and ANGPTL4<br>Change from baseline in urinary NGAL, and KIM-1