Cardioprotection of SGLT2 inhibitors in elderly diabetes: single-arm study

JRCT ID: jRCTs051190037

Registered date:15/08/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type2 Diabetes
• Date of first enrollment: 02/06/2020
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Patients receive the NHI-covered standard treatment for 6 months, add-on Luseogliflozin 2.5mg/day to standard treatment additional 6 months.

Outcome(s)

• Primary Outcome: Levels of changes in NT-proBNP before and after add-on Luseogliflozin therapy period

Secondary Outcome

Changes of NT-proBNP at 6 months from baseline.
Changes of several parameters at 6 months from baseline.
Changes of several parameters at 6 months after Luseogliflozin administration.

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1) Diagnosis of type 2 diabetes mellitus with NYHA Class 2 or 3
2) Glycosylated haemoglobin (HbA1c) of < 9%
3) NT-pro BNP > =400pg/ml
4) Age >= 65 years and <90 years
5) Prior to informed consent

Exclude criteria

1) Contraindications to Luseogliflozin
2) SGLT2 inhibitor therapy within 28 days prior to informed consent
3) eGFR <30 ml/min /1.73m2 or Dialysis
4) Life expectancy <6 months
5) Severe complication (significant liver disease (Child-Pugh classification B or C), active bleeding(intracranial hemorrhage, gastrointestinal bleeding, etc.), clinic blood pressure with a SBP of more than 180 mm Hg or a DBP of more than 110 mm Hg)
6) Patient with implantable defibrillator or pacemaker

Related Information

• Primary Sponsor: Matoba Satoaki
• Source(s) of Monetary Support: Taisho Pharmaceutical Co., Ltd.