PROTECT

JRCT ID: jRCTs071180041

Registered date:14/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type2 diabetes
• Date of first enrollment: 16/09/2015
• Target sample size: 480
• Study type: Interventional

Intervention(s)

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 increase the dose, it can be added and increased the dose of antidiabetic agents except for SGLT-2 inhibitor.
In principle, antidiabetic agents should not be added and the dose not be increased. Diet/Exercise therapy and administration of antidiabetic agents except for SGLT-2 are continued during treatment period. However, if it is insufficiently effective, it can be added and increased the dose of antidiabetic agents except for SGLT-2 inhibitor.

Outcome(s)

• Primary Outcome: Change in mean IMT of common carotid artery from baseline to month 24

Secondary Outcome

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, eEV,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,Fib4-Index, gamma-GTP, uric acid, serum creatinine, eGFR (adjusted value),Hb,Ht,Plt,ePV,and 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

Key inclusion & exclusion criteria

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

Include criteria

1) Type 2 diabetes with HbA1c (NGSP) >=6.0% and less than10.0% despite diet/exercise therapy or diet/exercise therapy adding antidiabetic agents for over three months
2)over 20 years of age at the time of informed consent acquisition and hospitalization or outpatient
3) The patient provided with information about the study,submitted written informed consent to it

Exclude 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 and 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

Related Information

• Primary Sponsor: Node Koichi
• Source(s) of Monetary Support: Astellas Pharma Inc
• Secondary ID(s): UMIN000018440