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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024969
Receipt No. R000028729
Scientific Title Two-way crossover comparison of tofogliflozin and canagliflozin using continuous glucose monitoring.
Date of disclosure of the study information 2016/11/24
Last modified on 2018/05/29

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Basic information
Public title Two-way crossover comparison of tofogliflozin and canagliflozin using continuous glucose monitoring.
Acronym Two-way crossover comparison of tofogliflozin and canagliflozin using continuous glucose monitoring.
Scientific Title Two-way crossover comparison of tofogliflozin and canagliflozin using continuous glucose monitoring.
Scientific Title:Acronym Two-way crossover comparison of tofogliflozin and canagliflozin using continuous glucose monitoring.
Region
Japan

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

Objectives
Narrative objectives1 To compare the glucose-lowering effect and glycemic variability of tofogliflozin with these of canagliflozin using continuous glucose monitoring (CGM).
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Glycemic control is estimated as the mean blood glucose (MBG), the area under the glucose curve above 10.0mmol/L (area under the curve [AUC]>10), and the percentage of time above 10.0mmol/L (t>10).The AUC is calculated using the trapezoidal method.
Intraday glycemic variability is assessed as the standard deviation (SD) and the mean amplitude of glycemic excursions (MAGE).
Day-to-day glycemic variability is assessed as the mean of daily difference (MODD).
Hypoglycemia, which is defined as a sensor value of <3.9mmol/L, was also calculated as a total time at <3.9mmol/L. Severe hypoglycemia is defined as a sensor value of <2.8mmol/L.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
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 The CGM examination is carried out at least 14 days after administering tofogliflozin. Tofogliflozin is changed to canagliflozin when the first CGM examination end.
Interventions/Control_2 The CGM examination is carried out at least 14 days after administering canagliflozin. Canagliflozin is changed to tofogliflozin when the first CGM examination end.
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients using SGLT2 inhibitor or the patients who judged a physician to need use of the SGLT2 inhibitor newly.
Key exclusion criteria Patients with diabetic nephropathy more than stage 3 (urinary albumin 300mg/gCr or urinary protein 0.5g/gCr) or with abnormal aspartate aminotransferase/alanine aminotransferase elevation (3 X the upper limit of normal) were excluded from this study.

Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yamada Satoru
Organization Kitasato University Kitasato Institute Hospital
Division name Diabetes Center
Zip code
Address 5-9-1 Shirokane, Minato-ku, Tokyo, Japan
TEL 03-3444-6161
Email Yamada-s@insti.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Inoue Gaku
Organization Kitasato University School of Pharmacy
Division name Center for Clinical Pharmacy and Clinical Sciences
Zip code
Address 5-9-1 Shirokane, Minato-ku, Tokyo, Japan
TEL 03-5791-6359
Homepage URL
Email inoueg@pharm.kitasato-u.ac.jp

Sponsor
Institute Kitasato University School of Pharmacy
Institute
Department

Funding Source
Organization Kitasato University School of Pharmacy
Organization
Division
Category of Funding Organization Other
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 11 Month 24 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 03 Month 19 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 04 Day
Last follow-up date
2017 Year 06 Month 28 Day
Date of closure to data entry
2017 Year 07 Month 03 Day
Date trial data considered complete
2017 Year 07 Month 03 Day
Date analysis concluded
2017 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 11 Month 24 Day
Last modified on
2018 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028729

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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