UMIN-CTR Clinical Trial

Basic information
Public title	Effect of canagliflozin for postprandial glucose control
Acronym	Effect of canagliflozin for postprandial glucose control
Scientific Title	Effect of canagliflozin for postprandial glucose control
Scientific Title:Acronym	Effect of canagliflozin for postprandial glucose control
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to compare changes in postprandial glucose level between canagliflozin and tofogliflozin using CGM (continuous glucose monitoring) in patient with type 2 diabetes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	total area under the glucose concentration curve for 3 hours after breakfast obtained from CGM
Key secondary outcomes	3 hours and 24 hours postprandial urinary glucose

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	Single administration of canagliflo zin and wash out and single administration of tofogliflozin
Interventions/Control_2	Single administration of tofogliflozin and wash out and single administration of canagliflozin
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	40 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1)The inpatients with type 2 diabetes,2)Patients who are capable of making a decision by themselves, and can provide written consent
Key exclusion criteria	1)Type 1 diabetes,2)Patients whose blood glucose level is less than 100 mg /dL on under insulin or sulfonylurea treatment, 3)Patients with postvoid residual urine of benign prostatic hyperplasia and neurogenic bladder,4)eGFR<30mL/min/1.73m2,5)Women who were pregnant, possibly pregnant, or were breast-feeding,6)Genital infection or urinary tract infection,7)Being treated diuretics,8)Insulin-dependent type 2 diabetes,9)Other patients who were considered to be ineligible for the study by the attending doctor
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasushi Tanaka
Organization	St Marianna University School of Medicine
Division name	Division of Metabolism and Endocrinology,Depertment of Internal Med icine
Zip code
Address	2-16-1, Sugao,Miyamae-ku, Kawasaki - shi, Kanagawa,japan
TEL	044-977-8111
Email	smu.tainai@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Satoshi Ishii
Organization	St Marianna University School of Medicine
Division name	Division of Metabolism and Endocrinology,Depertment of Internal Med icine
Zip code
Address	2-16-1, Sugao,Miyamae-ku, Kawasaki - shi, Kanagawa,japan
TEL	044-977-8111
Homepage URL
Email	s3ishii@marianna-u.ac.jp

Sponsor
Institute	St Marianna University School of Medicine
Institute
Department

Funding Source
Organization	NO
Organization
Division
Category of Funding Organization	Self funding
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	聖マリアンナ医科大学（神奈川県）

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Terminated
Date of protocol fixation	2017 Year 12 Month 18 Day
Date of IRB	2008 Year 02 Month 09 Day
Anticipated trial start date	2018 Year 01 Month 09 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 12 Month 27 Day
Last modified on	2019 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034938