UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020027 |
|---|---|
| Receipt number | 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 15:20:08 |
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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
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
masavasc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Department of Medical Genetics /
Gerontorgy
Institute
Department
Personal name
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
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
Value
https://center6.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 |
