UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030596 |
|---|---|
| Receipt number | R000034938 |
| Scientific Title | Effect of canagliflozin for postprandial glucose control |
| Date of disclosure of the study information | 2018/12/18 |
| Last modified on | 2019/07/11 08:49:31 |
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Basic information
Public title
Effect of canagliflozin for postprandial glucose control
Acronym
Effect of canagliflozin for postprandial glucose control
Scientific Title
Effect of canagliflozin for postprandial glucose control
Scientific Title:Acronym
Effect of canagliflozin for postprandial glucose control
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare changes in postprandial glucose level between canagliflozin and tofogliflozin using CGM (continuous glucose monitoring) in patient with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
total area under the glucose concentration curve for 3 hours after breakfast obtained from CGM
Key secondary outcomes
3 hours and 24 hours postprandial urinary glucose
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Single administration of canagliflo zin and wash out and single administration of tofogliflozin
Interventions/Control_2
Single administration of tofogliflozin and wash out and single administration of canagliflozin
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)The inpatients with type 2 diabetes,2)Patients who are capable of making a decision by themselves, and can provide written consent
Key exclusion criteria
1)Type 1 diabetes,2)Patients whose blood glucose level is less than 100 mg /dL on under insulin or sulfonylurea treatment, 3)Patients with postvoid residual urine of benign prostatic hyperplasia and neurogenic bladder,4)eGFR<30mL/min/1.73m2,5)Women who were pregnant, possibly pregnant, or were breast-feeding,6)Genital infection or urinary tract infection,7)Being treated diuretics,8)Insulin-dependent type 2 diabetes,9)Other patients who were considered to be ineligible for the study by the attending doctor
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Tanaka |
Organization
St Marianna University School of Medicine
Division name
Division of Metabolism and Endocrinology,Depertment of Internal Med icine
Zip code
Address
2-16-1, Sugao,Miyamae-ku, Kawasaki - shi, Kanagawa,japan
TEL
044-977-8111
smu.tainai@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Ishii |
Organization
St Marianna University School of Medicine
Division name
Division of Metabolism and Endocrinology,Depertment of Internal Med icine
Zip code
Address
2-16-1, Sugao,Miyamae-ku, Kawasaki - shi, Kanagawa,japan
TEL
044-977-8111
Homepage URL
s3ishii@marianna-u.ac.jp
Sponsor or person
Institute
St Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
NO
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
聖マリアンナ医科大学（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2008 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 27 | Day |
Last modified on
| 2019 | 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=R000034938
