Using TOfogliflozin for Possible better Intervention against Atherosclerosis for Type 2 Diabetes Patients

JRCT ID: jRCTs051180031

Registered date:24/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 Diabetes Mellitus
• Date of first enrollment: 12/01/2016
• Target sample size: 340
• Study type: Interventional

Intervention(s)

Group A: Tofogliflozin treatment group
Group B: Control group (continue conventional treatment other than SGLT2 inhibitors)

Outcome(s)

Primary Outcome

Changes in the IMT value (mean and max IMT) during a 104-week treatment period measured by carotid arterial echography
*Particularly focusing on the change of the mean of right and left meanIMT during 104 weeks of the study period

Secondary Outcome

1. changes in the indexes of glycemic control and beta cell function (HbA1c, fasting plasma glucose, c-peptide, fasting insulin, HOMA-beta, HOMA-R, and intact proinsulin/insulin ratio)
2. changes in the indexes of diabetic nephropathy and renal function (plasma creatinine, urinary albumin/creatinine, and eGFR)
3. changes in the indexes of lipid metabolism (TC, HDL-C, TG, LDL-C, and fatty acid 4-fractions (EPA/AA ratio))
4. changes in inflammation biomarker (hsCRP)
5. changes in the indexes of structural and functional biomarkers of arteriosclerosis and cardiovascular risks (baPWV, ABI, adiponectin, and NT-proBNP)
6. changes in the exploratory indexes whirh are related to diabetes mellitus and obesity (GPI-PLD, T-cadherin, and adiponectin-C1q complex)
7. Frequency of events (ischemic heart disease, cerebrovascular disorder, and arteriosclerosis obliterans)
8. Frequency of any adverse events
9. Score of Quality of Life (DTR-QOL7)

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

Only those patients who meet all of the following criteria are included:
1. Japanese T2D patients with poor glycemic control (HbA1c(NGSP) of 6% and above, and below 9.0%), and unable to achieve the blood glucose level stated in the Diabetes Treatment Guideline of 2014-2015, even though they are on drugs except SGLT2i with diet and physical therapy, or on diet and physical therapy only, for at least 12 weeks. Or, those on SGLT2i in the past, but have not used SGLT2i for at least 12 weeks before signing their consent form
2. Patients without any change on their antidiabetic, antithrombotic, or antihypertensive medication, or without taking therapeutic agent for dyslipidemia for at least 12 weeks before signing their consent form
3. Patients aged 30 to 74 at the time of giving their consent
4. Patient who are able to provide their consent form

Exclude criteria

Those patients who meet one of the following criteria are excluded:
1. Patients with type 1 diabetes, or secondary diabetes
2. Patients in the perioperative period, or with serious infection or injury
3. Patients with a history of myocardial infarction, angina, stroke, or cerebral infarction
4. Patients with severe renal dysfunction or end-stage renal failure (eGFR under 30)
5. Patients with serious liver functional impairment (AST:100 or above)
6. Patients with moderate to severe heart failure (class 3 or worse based on the New York Heart Association (NYHA)Functional Classification)
7. Patients with urinary tract infection, or genital infection
8. Patients who are pregnant, possibly pregnant, nursing, or planning to conceive a child
9. Patients who have a history of hypersensitiveness to the study drug
10. Patients with a malignant tumor or have a history of malignant tumor(exceptions: those are not on medication for malignant tumor, and have no recurrence of the disease so far and without recurrence risks during this study are allowed to participate)
11. Patients who are prohibited to use tofogliflozin
12. Other patients determined ineligible by an investigator

Related Information

• Primary Sponsor: Shimomura Iichiro
• Secondary Sponsor: Watada Hirotaka
• Source(s) of Monetary Support: Kowa Co., Ltd.
• Secondary ID(s): UMIN000017607