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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028634
Receipt No. R000032772
Scientific Title Multicenter trial of effects for glucometabolism, platelet activation marker and inflammatory marker by single or combinathin therapy with tofogliflozin and anagliptin in type 2 diabetic patients
Date of disclosure of the study information 2017/09/01
Last modified on 2017/08/10

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Basic information
Public title Multicenter trial of effects for glucometabolism, platelet activation marker and inflammatory marker by single or combinathin therapy with tofogliflozin and anagliptin in type 2 diabetic patients
Acronym Kansai - Collaborative Anti-atherothrombotic Medicine study group
Scientific Title Multicenter trial of effects for glucometabolism, platelet activation marker and inflammatory marker by single or combinathin therapy with tofogliflozin and anagliptin in type 2 diabetic patients
Scientific Title:Acronym Kansai - Collaborative Anti-atherothrombotic Medicine study group
Region
Japan

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

Objectives
Narrative objectives1 pass
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of HbA1c during 24 weeks from baseline
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 tofogliflozin
Interventions/Control_2 anagliptin
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
95 years-old >
Gender Male and Female
Key inclusion criteria 1. under treatment by dialy DPP-4 blocker
2. 7.5% < HbA1c < 9.0%
3. BMI > 18.0 kg/m2
4. 20 years < age < 95 years
5. written informed concent
Key exclusion criteria 1. type 1 diabetes or secondary diabetes
2. contraindication for medicine
3. allergy
4. eGFR < 30mL/min/1.73m2
5. AST or ALT > 120IU/L
6. history of appoplexy
7. pregnancy or lactationperiod
8. urinary infection, social disease
9. malignancy
10. inappropriate patients
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shosaku Nomura
Organization Kansai Medical University
Division name First Department of Internal Medicine
Zip code
Address 2-5-1, Shin-machi, Hirakata, Osaka 573-1010 Japan
TEL 0728042754
Email nomurash@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shosaku Nomura
Organization Kansai Medical University
Division name First Department of Internal Medicine
Zip code
Address 2-5-1, Shin-machi, Hirakata, Osaka 573-1010 Japan
TEL 0728042754
Homepage URL
Email nomurash@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization pass
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
2017 Year 09 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 Preinitiation
Date of protocol fixation
2017 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 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
2017 Year 08 Month 10 Day
Last modified on
2017 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032772

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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