Unique ID issued by UMIN | UMIN000017607 |
---|---|
Receipt number | R000020408 |
Scientific Title | Using TOfogliflozin for Possible better Intervention against Atherosclerosis for Type 2 Diabetes Patients |
Date of disclosure of the study information | 2015/05/19 |
Last modified on | 2019/07/05 10:44:05 |
Using TOfogliflozin for Possible better Intervention against
Atherosclerosis for Type 2 Diabetes Patients
UTOPIA study
Using TOfogliflozin for Possible better Intervention against
Atherosclerosis for Type 2 Diabetes Patients
UTOPIA study
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To evaluate the effect of the sodium-glucose cotransporter 2 inhibitor (SGLT2i), tofogliflozin, on the progression of atherosclerosis compared to a controlled group where SGLT2i is not administered.
Also to evaluate the effect of cardiovascular function and the blood biomarkers are examined.
Safety,Efficacy
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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
2
Treatment
Medicine |
Tofogliflozin treatment group, GroupA:
Clinical investigators will initiate tofogliflozin treatment.
Control group, GroupB:
Clinical investigators will continue conventional treatment using drugs other than Tofogliflozin.
30 | years-old | <= |
75 | years-old | > |
Male and Female
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
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
340
1st name | |
Middle name | |
Last name | Iichiro Shimomura/ Hirotaka Watada |
Osaka University Graduate School of Medicine/ Juntendo University Graduate School of Medicine
Department of Metabolic Medicine / Department of Medicine, Metabolism and Endocrinology
2-15 Yamadaoka, Suita-shi, Osaka / 2-1-1 Hongo, Bunkyo-ku, Tokyo
06-6879-5111
ichi@endmet.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Naoto Katakami |
Osaka University Graduate School of Medicine
Department of Metabolic Medicine
2-15 Yamadaoka, Suita-shi, Osaka
06-6879-5111
katakami@endmet.med.osaka-u.ac.jp
Osaka University Graduate School of Medicine
Kowa Company, Ltd.
Profit organization
NO
2015 | Year | 05 | Month | 19 | Day |
Unpublished
Completed
2015 | Year | 04 | Month | 23 | Day |
2015 | Year | 04 | Month | 23 | Day |
2015 | Year | 07 | Month | 01 | Day |
2019 | Year | 02 | Month | 26 | Day |
2015 | Year | 05 | Month | 18 | Day |
2019 | Year | 07 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020408
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