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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017607
Receipt No. 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

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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
Email 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
Email katakami@endmet.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020408

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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