UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014797 |
|---|---|
| Receipt number | R000017205 |
| Scientific Title | Fukuoka study of ipraglifrozin |
| Date of disclosure of the study information | 2014/08/08 |
| Last modified on | 2018/05/30 14:53:30 |
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Basic information
Public title
Fukuoka study of ipraglifrozin
Acronym
FUSION
Scientific Title
Fukuoka study of ipraglifrozin
Scientific Title:Acronym
FUSION
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and sfety of SGLT2 inhibitor, ipraglifrozin, in Japanese patients with type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glycemic control
Adverse effects
Key secondary outcomes
Atherosclerotic markers
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
iproglifrozin 50mg
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes with HbA1c =/> 6.4%
Key exclusion criteria
1. Type 1 diabetes
2. Patients with severe renal failure or liver dysfunction
3. Patients with drug allergy for ipraglifrozin
4. Patients with history of diabetec ketosis
5. Patients with shick day
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Yanase |
Organization
Fukuoka university, school of medicine
Division name
Department of endocrinology and diabetes mellitus
Zip code
Address
7-45-1 Nanakuma, Jyonan-ku, Fukuoka
TEL
092-801-1011
tyanase@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Nomiyama |
Organization
Fukuoka university, school of medicine
Division name
Department of endocrinology and diabetes mellitus
Zip code
Address
7-45-1 Nanakuma, Jyonan-ku, Fukuoka
TEL
092-801-1011
Homepage URL
http://crodot.jp/project_03_FUSION1/index.html
tnomiyama@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka university, school of medicine, department of endocrinology and diabetes mellitus
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
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
| 2014 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
HbA1c was reduced 0.6%, significantly.
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
| 2014 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 01 | Month | 15 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 08 | Day |
Last modified on
| 2018 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017205
