Lucent-J Study

JRCT ID: jRCTs051220016

Registered date:28/04/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes mellitus
• Date of first enrollment: 28/04/2022
• Target sample size: 40
• Study type: Interventional

Intervention(s)

Luseogliflozin group: Luseogliflozin will be orally administered at 2.5 mg once daily. If the effect is insufficient, the dose can be increased up to 5 mg.
Control group: Continue treatment with treatments other than SGLT2 inhibitors.

Outcome(s)

• Primary Outcome: Differences between the groups in the amount of change in myocardial microcirculatory reserve (MFR) 24 weeks after the start of administration

Secondary Outcome

1)The amount of change in the following items within each group and the difference between the groups at the point in time of each measurement (4,12 and 24 weeks) from the start of administration:Weight; BMI; systolic blood pressure; diastolic blood pressure; hemoglobin; hematocrit; total protein; albumin; total bilirubin;AST; ALT; GTP; creatinine; eGFR; LDH; Ca; Na; K; Cl; LDL-C; HDL-C; TG; uric acid; CRP; FBS; IRI; HbA1c; acetacetic acid; B-hydroxybutyric acid; BNP;adrenomedulin; urinary albumin creatinine ratio and LVEF.
(2) Difference in the amount of change in MFR between the high MFR value group and the low MFR value group before administration.

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Type 2 diabetic patients age 50 and over
2)Patients with HbA1c 8.5% or less (Most recent HbA1c within 13 weeks prior to consent)
3)Patients who received an ammonia PET examination before the date of consent acquisition, and MFR of 3.0 or less (Most recent MFR within 13 weeks prior to consent)
4)Patients with written consen

Exclude criteria

1) Patients with heart disease (myocardial infarction, cardiomyopathy, atrial fibrillation, severe valvular disease)
2) Patients who underwent cardiac bypass surgery or catheter treatment for ischemic heart disease within 13 weeks prior to consent
3) Patients with coronary artery disease who are indicated for coronary revascularization, or patients with suspected coronary artery disease who are indicated for coronary angiography
4) Persons with severe renal dysfunction
5) Patients with severe hepatic dysfunction (ALT or AST is 5 times or more of the standard value)
6) Patients with a malignant tumor currently being treated or during palliative care
7) Patients participating in or planning to participate in intervention studies using other medicines or medical devices
8) Smokers
9) Pregnant or lactating women
10) Patients with contraindications to luseogliflozin (hypersensitivity, severe ketosis, diabetic coma, severe infections, before or after surgery, serious trauma)
11) In the young old (65=<age<75) and latter-stage elderly (75=<age), it is a patient of the geriatric syndrome or BMI=<18
12) Patients who received SGLT2 inhibitors from 13 weeks before the ammonia PET examination to the date of consent acquisition
13) Patients who have newly started or changed or discontinued diabetes treatment drugs, nitroglycer in preparations, vasodilators, and antihypertensive drugs within 13 weeks before obtaining consent. However, temporary drug changes are allowed due to suspected ischemia on ammonia PET scans.
14) Patients whose participation in this study is deemed inappropriate by the investigator or co-investigator

Related Information

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