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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018265
Receipt No. R000021137
Scientific Title Direct comparison of TOfogliflozin and iPragliflozin on hyper-hypoglycemia using Continuous Glucose Monitoring system (TOP-CGM)
Date of disclosure of the study information 2015/07/10
Last modified on 2016/09/12

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Basic information
Public title Direct comparison of TOfogliflozin and iPragliflozin
on hyper-hypoglycemia using Continuous Glucose Monitoring system (TOP-CGM)
Acronym Tofogliflozin and continuous glucose monitoring
Scientific Title Direct comparison of TOfogliflozin and iPragliflozin
on hyper-hypoglycemia using Continuous Glucose Monitoring system (TOP-CGM)
Scientific Title:Acronym Tofogliflozin and 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 SGLT2 inhibitors, tofogliflozin and ipragliflozin on hyper-hypoglycemia using continuous glucose monitoring system -randomized cross-over study-
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time under 70mg/dl using continuous glucose monitoring system
Key secondary outcomes (1) CGMS measurements
(2) Changes in the variables listed below.
1-Fasting plasma glucose and HbA1c(NGSP value)
2-serum creatinine, BUN, Na, K, ,Cl, Mg, Ca, P, uric acid,ketone bodies(total ketone body, Acetoacetic acid and beta-hydroxybutyrate), glycemic related hormones(proinsulin, insulin, c-peptide, glucagon, free fatty acid)
3-urinanalysis(Na, K, Cl, Ca, creatinine, urine volume, urine glucose)
4- Reactive hyperemia index (RHI)
(3) Meal tolerance test measurements

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 Tofogliflozin and wash out and Ipragliflozin
Interventions/Control_2 Ipragliflozin and wash out and Tofogliflozin
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
65 years-old >
Gender Male and Female
Key inclusion criteria (1)Diagnosed as Type 2 diabetes
(2)20=<informed conscent age<65
(3)22.0=<BMI<45
(4)Registration inspection before 4 weeks or more, patients are administered without prescription change in the regimen of diet and exercise therapy and SU
(5) With estimated glomerular function >= 45 ml/min/1.73m2
(6)Subjects who give consent document about participation in the clinical study
Key exclusion criteria (1) Has hypersensitivity to tofogliflozin and ipragliflozin or any other excipient of them
(2) With severe ketosis, diabetic coma, or precoma
(3) With severe infection, pre or post-surgery, and serious trauma
(4)Has arteriosclerotic disease (myocardial infarction, stroke and so on) and history of them
(5) End-stage renal disease (ESRD) undergoing hemodialysis
(6) With severe liver dysfunction
(7) Has insulin therapy
(8) Entered already with another clinical trials
(9) Considered as inadequate by the investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yosuke Okada
Organization University of Occupational and Environmental Health
Division name First Department of Internal Medicine, School of Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi 807-8555, Japan
TEL +8100936031611
Email y-okada@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Mori
Organization University of Occupational and Environmental Health
Division name First Department of Internal Medicine, School of Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi 807-8555, Japan
TEL +8100936031611
Homepage URL
Email morihiro@med.uoeh-u.ac.jp

Sponsor
Institute University of Occupational and Environmental Health
Institute
Department

Funding Source
Organization KOWA COMPANY,LTD
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
2015 Year 07 Month 10 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 Enrolling by invitation
Date of protocol fixation
2015 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 13 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
2015 Year 07 Month 10 Day
Last modified on
2016 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021137

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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