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Recruitment status Completed
Unique ID issued by UMIN UMIN000014797
Receipt No. R000017205
Scientific Title Fukuoka study of ipraglifrozin
Date of disclosure of the study information 2014/08/08
Last modified on 2018/05/30

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email tnomiyama@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka university, school of medicine, department of endocrinology and diabetes mellitus
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017205


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