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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020027
Receipt No. R000023128
Scientific Title Effect of SGLT2 inhibitor, canagliflozin, for the size of lipid particles
Date of disclosure of the study information 2016/02/01
Last modified on 2019/04/05

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Basic information
Public title Effect of SGLT2 inhibitor, canagliflozin, for the size of lipid particles
Acronym Effect of canagliflozin for the size of lipid particles
Scientific Title Effect of SGLT2 inhibitor, canagliflozin, for the size of lipid particles
Scientific Title:Acronym Effect of canagliflozin for the size of lipid particles
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the effect of SGLT2 inhibitor, canagliflozin, for lipid particle size, small dense LDL particle in patrticular.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of the data of 20 lipoproteins fractions measured by high-performance gel permeation chromatography at 3 months after canagliflozin administration
Key secondary outcomes 1) Change of hemoglobin A1c (HbA1c) for 3 months at 3 months after canagliflozin administration
2) Change of body mass and body mass index (BMI) at 3 months after canagliflozin administration
3) Change of blood biochemical value at 3 months after canagliflozin administration

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 To prescribe canagliflozin
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)Patients of type 2 diabetes with HbA1c>=7.0
2)Paitents over 20 years old and under 75 years old
3)Patients give written informed consent
Key exclusion criteria 1) History of hypersensitivity of canagliflozin
2) Severe ketosis, diabetic coma or precoma
3) Severe infection, pre or post surgery, or severe trauma
4) Patients taking fibrate-based medicines or pioglitazone
5) Patients taking diuretic medicines
6) eGFR < 45 mL/min/1.73 m2 or artificial dialysis
7) Considered as inadequate by the investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Yoshida
Organization Tokyo Medical and Dental University
Division name Medical Genetics/ Geriatrics
Zip code
Address 1-5-45 Yushima, Bunkyoku, Tokyo, Japan
TEL 03-5803-4617
Email masavasc@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Yoshida
Organization Tokyo Medical and Dental University
Division name Medical Genetics/ Geriatrics
Zip code
Address 1-5-45 Yushima, Bunkyoku, Tokyo, Japan
TEL 03-5803-4617
Homepage URL
Email masavasc@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Department of Medical Genetics /
Gerontorgy
Institute
Department

Funding Source
Organization Tanabe mitsubishi Pharma
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

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 01 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
2016 Year 01 Month 22 Day
Date of IRB
2016 Year 01 Month 21 Day
Anticipated trial start date
2016 Year 01 Month 23 Day
Last follow-up date
2017 Year 01 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 01 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023128

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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