UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of canagliflozin on the glycemic control and plasma GLP-1 levels.
Title of the study (Brief title)	Effects of canagliflozin on the glycemic control and plasma GLP-1 levels.
Region	Japan

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

Objectives
Narrative objectives1	To investigate the influence of canagliflozin on postprandial changes in glucose and GLP-1 levels after 12 weeks of treatment in patients with type 2 diabetes mellitus inadequately controlled.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Postprandial changes in glucose and GLP-1 levels after 12 weeks of treatment with canagliflozin
Key secondary outcomes	1) Change in glycemic parameters, body weight, waist circumference, and glucagon after 12 weeks of treatment with canagliflozin. 2) Continuous glucose monitoring

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	Subjects take Canagliflozin 100mg once a day 1 for 12 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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) HbA1c levels of >=6.5% to <8.5% (NGSP) 2) Age >=20 to <75 years on the date of submission of informed consent 3) Under treatment with fixed diet and exercise therapy >=8weeks 4) When treated with oral antidiabetic drugs; under treatment with a fixed dose and regimen >=8 weeks 5) Submission of written informed consent for participation in this study
Key exclusion criteria	1) Type 1 diabetes, diabetes due to a pancreatic disorder, or secondary diabetes due to conditions 2) Application of contraindications contained in the package insert 3) Severe renal function disorder 4)BMI is < 22kg/m2 5) Under treatment with insulin,GLP-1 analog, or SGLT2 inhibitor 6) Pregnant women, women suspected of being pregnant, or lactating women 7) Participation in the study is judged by the investigator or sub-investigator as inappropriate for any other reason
Target sample size	45

Research contact person
Name of lead principal investigator	Takeshi Osonoi
Organization	Nakakinen clinic
Division name	Director
Address	745-5, Nakadai, Naka, Ibaraki
TEL	029-353-2800
Email	t-osonoi@kensei-kai.com

Public contact
Name of contact person	Kensuke Ofuchi
Organization	Nakakinen clinic
Division name	Clinical Laboratory
Address	45-5, Nakadai, Naka, Ibaraki
TEL	029-353-2800
Homepage URL
Email	k-ofuchi@kensei-kai.com

Sponsor
Institute	Nakakinen clinic
Institute
Department

Funding Source
Organization	Mitsubishi Tanabe Pharma Corporation
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	仲本内科クリニック（茨城県）、那珂記念MITOクリニック（茨城県）

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 24 Day
Anticipated trial start date	2015 Year 07 Month 17 Day
Last follow-up date	2016 Year 03 Month 10 Day
Date of closure to data entry	2016 Year 03 Month 10 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 08 Month 30 Day

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

Management information
Registered date	2015 Year 07 Month 17 Day
Last modified on	2016 Year 09 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021232