UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024922 |
|---|---|
| Receipt number | R000028670 |
| Scientific Title | Comparative trial of SGLT2-inhibitor (Canagliflozin) and sulfonylurea (Glimepiride) for patients with DM |
| Date of disclosure of the study information | 2016/11/21 |
| Last modified on | 2018/07/11 15:32:47 |
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Basic information
Public title
Comparative trial of SGLT2-inhibitor (Canagliflozin) and sulfonylurea (Glimepiride) for patients with DM
Acronym
Comparative trial of SGLT2-inhibitor (Canagliflozin) and sulfonylurea (Glimepiride) for patients with DM
Scientific Title
Comparative trial of SGLT2-inhibitor (Canagliflozin) and sulfonylurea (Glimepiride) for patients with DM
Scientific Title:Acronym
Comparative trial of SGLT2-inhibitor (Canagliflozin) and sulfonylurea (Glimepiride) for patients with DM
Region
| Japan |
Condition
Condition
Diabetes mellitus type 2
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Influence of SGLT2-inhibitor (Canagliflozin) and and sulfonylurea (Glimepiride) for patients with DMi
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
somatic fat volume (CT)
Key secondary outcomes
HbA1c
Body weight, body fat percentage
somatic fat volume (CT)
BNP
serum Cr,eGFR
glycoalbumin
U-alb, U-type IV collagen
cystatin C, ox-LDL, Lp (a), EPA/AA
T-cho,LDL,HDL.TG
Bood pressure
FMD, ABI, PWV
complication
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are 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
SGLT2-inhibitor (Canagliflozin) 100mg/day, one year
Interventions/Control_2
sulfonylurea ((Glimepiride) ) 2~6mg/day, one year
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Diabetes mellitus type 2
Patients from whom informed consent was obtained
Key exclusion criteria
Patients who were deemed not appropriate to participate in this study by doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Sezai |
Organization
Nihon University School of Medicine
Division name
Department of Cardiovascular Surgery
Zip code
Address
30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
asezai.med@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Sezai |
Organization
Nihon University School of Medicine
Division name
Department of Cardiovascular Surgery
Zip code
Address
30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
asezai.med@gmail.com
Sponsor or person
Institute
Sekino Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
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
関野病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 21 | 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 | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 21 | Day |
Last modified on
| 2018 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028670
