IMeglimin for exercise CApacity in Patients with HF and diabetes

JRCT ID: jRCTs031220712

Registered date:17/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart failure with diabetes mellitus
• Date of first enrollment: 17/03/2023
• Target sample size: 44
• Study type: Interventional
• Intervention(s): Oral administration of imeglimin (1000mg) or placebo twice daily

Outcome(s)

• Primary Outcome: Change in peak oxygen consumption assessed by cardiopulmonary exercise testing from baseline to week 12 after intervention

Secondary Outcome

-Change in ventilatory equivalent for carbon dioxide slope assessed by cardiopulmonary exercise testing
-Change in N-terminal pro-brain natriuretic peptide levels from baseline to week 12 after intervention
-Change in left ventricular ejection fraction and left ventricular diastolic function assessed by echoca
rdiography from baseline to week 12 after intervention
-Change in fasting blood glucose levels from baseline to week 12 after intervention
-Change in glycated hemoglobin levels from baseline to week 12 after intervention
-Hospitalization for heart failure
-Incident cardiovascular death

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Age 20 and greater
-Diagnosed with heart failure and diabetes mellitus
-Under outpatient cardiac rehabilitation program
-Under no treatments or one anti-diabtic agent for diabetes mellitus
-Written informed consent provided

Exclude criteria

-Hypersensitivity to Imeglimin
-Diabetic coma or severe ketosis
-Type 1 diabetes
-Severe infectious disease
-Renal dysfunction (eGFR<45 mL/min/1.73 m2 or under dialysis)
-Pregnancy
-Nursing
-Any participant judged not suitable for this study by investigators

Related Information

• Primary Sponsor: Naito Ryo
• Source(s) of Monetary Support: Sumitomo Pharma Co., Ltd.