UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the utility, and palatability of meal in novel SGLT-2 inhibitor ipragliflozin
Title of the study (Brief title)	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

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	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

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	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	Kazuo Kanno
Organization	Association of medical corporation Ouitsu-kai, Kanno Clinic
Division name	Medical director
Address	3-44-17, Shimorenjaku, Mitaka-city, Tokyo
TEL	0422-40-5022
Email	kzkanno@gmail.com

Public contact
Name of contact person	Kazuo Kanno
Organization	Association of medical corporation Ouitsu-kai, Kanno-naika
Division name	Medical director
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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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