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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014195
Receipt No. R000016529
Scientific Title Study on the utility, and palatability of meal in novel SGLT-2 inhibitor ipragliflozin
Date of disclosure of the study information 2014/06/06
Last modified on 2016/07/06

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Basic information
Public title Study on the utility, and palatability of meal in novel SGLT-2 inhibitor ipragliflozin
Acronym Study on the utility, and palatability of meal in novel SGLT-2 inhibitor ipragliflozin
Scientific Title Study on the utility, and palatability of meal in novel SGLT-2 inhibitor ipragliflozin
Scientific Title:Acronym Study on the utility, and palatability of meal in novel SGLT-2 inhibitor ipragliflozin
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 the efficacy and safety under clinical use condition of ipragliflozin. To investigate the influences of dietry composition (intake of carbohydrate and lipid) to the efficacy and safety, and the change of palatability (appetite, incentive to sugar, degree of acquisition desire).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in HbA1c from baseline to 24 weeks
Key secondary outcomes 1) Change and percent change in following
items from baseline to 4 week, 12 week,
and 24 week

fasting plasma glucose
HbA1c (Except for the change at 24 week)
Body weight

2) Stratification analysis on efficacy of
ipragliflozin

Dietary composition with BDHQ (intake of
carbohydrate and lipid)

3) Palatability change of diet (appetite,
incentive to sugar, degree of acquisition
desire)

Comparison of ipragliflozin treated group with other medicated group

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 Orally administration of 50mg ipragliflozin once a day, pre or post breakfast for 24 weeks
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

Not applicable
Gender Male and Female
Key inclusion criteria Japanese patient who meets all the following inclusion criteria
1) Type 2 diabetes patients with untreated or treated with hypoglycemic agent
2) 20 years and older
3) BMI >= 22kg/m2
4) HbA1c >= 6.5%
5) Received written informed consent
Key exclusion criteria 1) With severe ketosis, history of diabetic or precoma, severe infection, pre or post surgery, and severe trauma, hypersensitivity to ipragliflozin or any other excipient of ipragriflozin
2) With hypophyseal dysfunction or adrenal insufficiency who have high possibility of induces hypoglycemia
3) With urinary tract or genital infection
4) With severe hepatic dysfunction
5) Is receiving SGLT-2 inhibitors at initiation of this study
6) Is nursing or pregnant or planned to become pregnant
7) Considered as inadequate by the investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Kanno
Organization Association of medical corporation Ouitsu-kai, Kanno Clinic
Division name Medical director
Zip code
Address 3-44-17, Shimorenjaku, Mitaka-city, Tokyo
TEL 0422-40-5022
Email kzkanno@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kazuo Kanno
Organization Association of medical corporation Ouitsu-kai, Kanno-naika
Division name Medical director
Zip code
Address 3-44-17, Shimorenjaku, Mitaka-city, Tokyo
TEL 0422-40-5022
Homepage URL
Email kzkanno@gmail.com

Sponsor
Institute Association of medical corporation Ouitsu-kai, Kanno-naika
Institute
Department

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 06 Month 06 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2014 Year 06 Month 05 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 09 Day
Last follow-up date
2015 Year 09 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 06 Day
Last modified on
2016 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016529

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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