Type 2 diabetes
Conditions
Interventions
Administration of ipragliflozin 50 mg once a day pre or post breakfast. When it is insufficiently effective, it can be increased to 100 mg once a day. When it is insufficient effective inspite of incr
Sponsors
Department of Cardiovascular Medicine, Saga University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Type 2 diabetes with HbA1c (NGSP) >=6.0% and <10.0% nevertheless diet/exercise therapy or diet/exercise therapy adding antidiabetic agents for >=3 months 2) >=20 of age at the time of informed consent acquisition and hospitalization or outpatient 3) The patient provided written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1) Type 1 diabetes 2) Has history of severe ketosis, diabetic coma, or precoma within 6 months 3) Has severe infection, serious trauma, or pre or post surgery (including carotid endarterectomy and stent implantation) 4) With severe renal dysfunction (eGRF <45 mL/min/1.73m2 or patient undergoing artificial dialysis) 5) Has history of myocardial infarction, angina, percutaneous transluminal coronary angioplasty, coronary artery bypass graft, cerebral infarction, intracranial hemorrhage, subarachnoid hemorrhage, transient ischemic attacks within 3 months before initiation of the study 6) Heart failure patient whose NYHA functional classification is III or IV 7) Has history of administration of SGLT-2 within 1 month before initiation of the study 8) Pregnant, possibly pregnant, planned to become pregnant or nursing women 9) Has history of hypersensitivity to ipragliflozin or any other excipient of ipragliflozin 10) Are considered not eligible for the study by the attending doctor due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean IMT of common carotid artery from baseline to month 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in mean IMT of carotid bulb and mean IMT of internal carotid artery from baseline to month 24 2) Change in max IMT of common carotid artery, max IMT of carotid bulb, and max IMT of internal carotid artery from baseline to month 24 3) Mean of mean IMT of common carotid artery, carotid bulb, and internal carotid artery, respectively and change in it from baseline to month 24 4) Mean of max IMT of common carotid artery, carotid bulb, and internal carotid artery, respectively and change in it from baseline to month 24 5) Values and change in following items of laboratory test from baseline to month 24 High sensitivity CRP, MDA-LDL, NT-proBNP, high molecular weight adiponectin 6) Values and change in following items of laboratory test from baseline to month 12 and 24 Blood pressure, body weight, BMI, waist circumference visceral fat and subcutaneous fat area (abdominal CT, month 24 only), HbA1c (NGSP), fasting blood glucose, serum lipid [TC, LDL-C (Direct method), HDL-C, TG, Non-HDL-C], AST, ALT, gamma-GTP, uric acid, serum creatinine, eGFR (adjusted value), excretion of urinary albumin (creatinin equivalent) 7) Values and change in following items of cardiovascular function test from baseline to month 24 Echocardiography (LAVI, %EF, LVMI, E/A, DT, E/e', IVCd), FMD, PWV, CAVI, AI | — |
Countries
Japan
Contacts
Public ContactKoichi Node
Saga University Department of Cardiovascular Medicine
Outcome results
None listed