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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018345
Receipt No. R000021232
Scientific Title Effects of canagliflozin on the glycemic control and plasma GLP-1 levels.
Date of disclosure of the study information 2015/08/18
Last modified on 2016/09/06

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Basic information
Public title Effects of canagliflozin on the glycemic control and plasma GLP-1 levels.
Acronym Effects of canagliflozin on the glycemic control and plasma GLP-1 levels.
Scientific Title Effects of canagliflozin on the glycemic control and plasma GLP-1 levels.
Scientific Title:Acronym 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
1st name
Middle name
Last name Takeshi Osonoi
Organization Nakakinen clinic
Division name Director
Zip code
Address 745-5, Nakadai, Naka, Ibaraki
TEL 029-353-2800
Email t-osonoi@kensei-kai.com

Public contact
Name of contact person
1st name
Middle name
Last name Kensuke Ofuchi
Organization Nakakinen clinic
Division name Clinical Laboratory
Zip code
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)

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 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

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 Completed
Date of protocol fixation
2015 Year 06 Month 24 Day
Date of IRB
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

Other
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

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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