UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public title
Using TOfogliflozin for Possible better Intervention against
Atherosclerosis for Type 2 Diabetes Patients
Acronym
UTOPIA study
Scientific Title
Using TOfogliflozin for Possible better Intervention against
Atherosclerosis for Type 2 Diabetes Patients
Scientific Title:Acronym
UTOPIA study
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tofogliflozin treatment group, GroupA:
Clinical investigators will initiate tofogliflozin treatment.
Interventions/Control_2
Control group, GroupB:
Clinical investigators will continue conventional treatment using drugs other than Tofogliflozin.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion 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
Key exclusion 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
Target sample size
340
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Iichiro Shimomura/ Hirotaka Watada |
Organization
Osaka University Graduate School of Medicine/ Juntendo University Graduate School of Medicine
Division name
Department of Metabolic Medicine / Department of Medicine, Metabolism and Endocrinology
Zip code
Address
2-15 Yamadaoka, Suita-shi, Osaka / 2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
06-6879-5111
ichi@endmet.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoto Katakami |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Metabolic Medicine
Zip code
Address
2-15 Yamadaoka, Suita-shi, Osaka
TEL
06-6879-5111
Homepage URL
katakami@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kowa Company, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 18 | Day |
Last modified on
| 2019 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020408
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| Registered date | File name |
| Research case data | |
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