UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032601 |
|---|---|
| Receipt number | R000037176 |
| Scientific Title | The Extension study : Using TOfogliflozin for Possible better Intervention against Atherosclerosis for Type 2 Diabetes Patients |
| Date of disclosure of the study information | 2018/05/15 |
| Last modified on | 2022/11/17 12:45:27 |
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Basic information
Public title
The Extension study : Using TOfogliflozin for Possible better Intervention against Atherosclerosis for Type 2 Diabetes Patients
Acronym
The Extension study : Using TOfogliflozin for Possible better Intervention against Atherosclerosis for Type 2 Diabetes Patients (UTOPIA Ex study)
Scientific Title
The Extension study : Using TOfogliflozin for Possible better Intervention against Atherosclerosis for Type 2 Diabetes Patients
Scientific Title:Acronym
The Extension study : Using TOfogliflozin for Possible better Intervention against Atherosclerosis for Type 2 Diabetes Patients (UTOPIA Ex study)
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the long-term efficacy and safety of SGLT2 inhibitor (tofogliflozin) to prevent the progression of arteriosclerosis by extend the observation period for 2 years after the main study (Using TOfogliflozin for Possible better Intervention against Atherosclerosis for Type 2 Diabetes Patients / UTOPIA study)
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), measured by carotid arterial echography, from the start of main study (UTOPIA study) to the end of the observation period in this Extension study (208 week)
*Particularly focusing on the change of the mean of right and left mean IMT during 208 weeks of the study period
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Subjects who had participated in the main study (UTOPIA study), and who agree to participate in this Extension study by providing their consent form
Key exclusion criteria
Those subjects who meet one of the following criteria are excluded:
1. subjects who disagree to participate in this Extension study
2. subjects 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 Pharmaceutical Co. 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
| 2018 | Year | 05 | Month | 15 | 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
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 08 | Month | 06 | Day |
Date analysis concluded
Other
Other related information
To evaluate the long-term efficacy and safety of SGLT2 inhibitor (tofogliflozin) to prevent the progression of arteriosclerosis by extend the observation period for 2 years after the main study (UTOPIA study).
In the extended observation period, any antidiabetic agents are allowed both in A group (tofogliflozin group) and B group (control group).
Management information
Registered date
| 2018 | Year | 05 | Month | 15 | Day |
Last modified on
| 2022 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037176
