UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of DPP4 inhibitors versus luseogliflozin, a SGLT2 inhibitor using cotinuous glucose monitoring (CGM)
Title of the study (Brief title)	Comparison of DPP4 inhibitors versus luseogliflozin, a SGLT2 inhibitor using cotinuous glucose monitoring (CGM)
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We compare the glucose flustuation between DPP4 inhibitors and SGLT2 inhibitor, luseogliflozin by using CGM
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	CGM(BS average, SD, MAGE, M-value, AUC)
Key secondary outcomes

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	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Luseogliflozin
Interventions/Control_2	DPP4 inhibitors
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	type 2 diabetes using DPP4 inhibitors
Key exclusion criteria	liver or renal dysfunction
Target sample size	20

Research contact person
Name of lead principal investigator	Nobutoshi Fushimi
Organization	Ichinomiyanishi hospital
Division name	Department of Endocrinology and Diabetes
Address	Ichinomiya, Japan
TEL	0586-48-0077
Email	nobutoshi243@yahoo.co.jp

Public contact
Name of contact person	Nobutoshi Fushimi
Organization	Ichinomiyanishi hospital
Division name	Department of Endocrinology and Diabetes
Address	Ichinomiya, Japan
TEL	0586-48-0077
Homepage URL
Email	nobutoshi243@yahoo.co.jp

Sponsor
Institute	Ichinomiyanishi hospital
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	None
Organization
Division
Category of Funding Organization	Self funding
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	一宮西病院（愛知県） Ichinomiya Nishi Hospital(Ichinomiya-City,Aichi-pref.)

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 25 Day
Anticipated trial start date	2014 Year 07 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 06 Month 21 Day
Last modified on	2016 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016686